Trial Outcomes & Findings for High Intensity Interval Training In pATiEnts With Intermittent Claudication (NCT NCT04042311)
NCT ID: NCT04042311
Last Updated: 2024-11-14
Results Overview
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
From the first to last exercise session, i.e. from week 0 to week 6.
Results posted on
2024-11-14
Participant Flow
Participant milestones
| Measure |
High-Intensity Interval Training
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
Participants Enrolled in Workstream 1
|
30
|
|
Overall Study
Participants Completing Workstream 1
|
15
|
|
Overall Study
Participants Enrolled in Workstream 2
|
40
|
|
Overall Study
Participants Completing Workstream 2
|
31
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
High-Intensity Interval Training
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Overall Study
Abnormal cardiopulmonary exercise test (CPET) or unable to achieve a maximal test
|
9
|
|
Overall Study
Unable to tolerate
|
4
|
|
Overall Study
Concurrent illness
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
No longer meeting inclusion criteria
|
2
|
|
Overall Study
No reason given
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Workstream 1, n=30 Workstream 2, n=40
Baseline characteristics by cohort
| Measure |
High-Intensity Interval Training (Workstream 1)
n=30 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
High-Intensity Interval Training (Workstream 2)
n=40 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 9 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
69 years
STANDARD_DEVIATION 8 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
69 years
STANDARD_DEVIATION 9 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
5 Participants
n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
12 Participants
n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Sex: Female, Male
Male
|
23 Participants
n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
35 Participants
n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
58 Participants
n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
168.5 cm
STANDARD_DEVIATION 7.2 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
169.1 cm
STANDARD_DEVIATION 10.0 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
168.7 cm
STANDARD_DEVIATION 8.3 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Weight
|
81.6 kg
STANDARD_DEVIATION 16.2 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
79.9 kg
STANDARD_DEVIATION 14.5 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
80.6 kg
STANDARD_DEVIATION 15.2 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
body mass index (BMI)
|
28.5 kg/m^2
STANDARD_DEVIATION 4.0 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
28.0 kg/m^2
STANDARD_DEVIATION 3.9 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
28.2 kg/m^2
STANDARD_DEVIATION 3.9 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Systolic blood pressure
|
146 mmHg
STANDARD_DEVIATION 20 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
146 mmHg
STANDARD_DEVIATION 20 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
146 mmHg
STANDARD_DEVIATION 19 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Diastolic blood pressure
|
79 mmHg
STANDARD_DEVIATION 8 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
81 mmHg
STANDARD_DEVIATION 13 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
80 mmHg
STANDARD_DEVIATION 11 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Ankle-brachial pressure index (ABPI) (worst leg)
|
0.64 Index
STANDARD_DEVIATION 0.20 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
0.63 Index
STANDARD_DEVIATION 0.21 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
0.63 Index
STANDARD_DEVIATION .21 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Intermittent claudication distance (ICD)
|
118.6 metres
STANDARD_DEVIATION 109.9 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
130.2 metres
STANDARD_DEVIATION 88.8 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
125.1 metres
STANDARD_DEVIATION 97.9 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Maximum Walking Distance (MWD)
|
283 metres
STANDARD_DEVIATION 190.5 • n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
327.5 metres
STANDARD_DEVIATION 206.8 • n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
307.9 metres
STANDARD_DEVIATION 199.6 • n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Smoking status
Current
|
11 Participants
n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
13 Participants
n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
24 Participants
n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Smoking status
Ex
|
17 Participants
n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
22 Participants
n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
39 Participants
n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Smoking status
Non-smoker
|
2 Participants
n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
5 Participants
n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
7 Participants
n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
|
Best medical therapy (BMT)
|
26 Participants
n=30 Participants • Workstream 1, n=30 Workstream 2, n=40
|
30 Participants
n=40 Participants • Workstream 1, n=30 Workstream 2, n=40
|
56 Participants
n=70 Participants • Workstream 1, n=30 Workstream 2, n=40
|
PRIMARY outcome
Timeframe: From the first to last exercise session, i.e. from week 0 to week 6.Population: Workstream 1 = 30 participants Workstream 2 = 40 participants
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Outcome measures
| Measure |
High-Intensity Interval Training
n=70 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Tolerability Test - Related Withdrawals
Workstream 1 - unable to tolerate HIIT or CPEX
|
1 Participants
|
|
Tolerability Test - Related Withdrawals
Workstream 2 - unable to tolerate HIIT or CPEX
|
3 Participants
|
PRIMARY outcome
Timeframe: From study opening to completion/withdrawal of the last patientPopulation: The overall number of participants analysed in the number of patients screened. Each row then represents the number of patients eligible vs. screened, the number recruited vs. eligible and the number completed vs. recruited.
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Outcome measures
| Measure |
High-Intensity Interval Training
n=424 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Feasibility Test
Workstream 1 - screened
|
144 participants
|
|
Feasibility Test
Workstream 1 - eligible
|
95 participants
|
|
Feasibility Test
Workstream 1 - recruited
|
30 participants
|
|
Feasibility Test
Workstream 1 - completed
|
15 participants
|
|
Feasibility Test
Workstream 2 - screened
|
280 participants
|
|
Feasibility Test
Workstream 2 - eligible
|
165 participants
|
|
Feasibility Test
Workstream 2 - recruited
|
40 participants
|
|
Feasibility Test
Workstream 2 - completed
|
31 participants
|
PRIMARY outcome
Timeframe: From the first to last exercise session, i.e. from week 0 to week 6.Population: Includes all participants that completed the programme and the type of units is the number of HIIT intervals completed. The number analysed is the total amount of intervals completed per workstream. The count of units is the number of intervals where the required intensity was achieved.
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Outcome measures
| Measure |
High-Intensity Interval Training
n=7998 Number of HIIT intervals
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Tolerability Test - Achieving the Required Intensity
Workstream 1 - intervals at the required intensity
|
2210 Number of HIIT intervals
|
|
Tolerability Test - Achieving the Required Intensity
Workstream 2 - intervals at the required intensity
|
4546 Number of HIIT intervals
|
PRIMARY outcome
Timeframe: From the first to last exercise session, i.e. from week 0 to week 6.Population: Includes all participants that completed the programme and the type of units is the number of HIIT sessions completed. The number analysed is the total amount of planned sessions per workstream. The count of units is the number of sessions that were actually attended.
Considers the number of sessions completed compared to the theoretical number.
Outcome measures
| Measure |
High-Intensity Interval Training
n=828 Number of HIIT sessions
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Tolerability Test - Number of Sessions Completed
Workstream 1 - HIIT sessions completed
|
270 Number of HIIT sessions
|
|
Tolerability Test - Number of Sessions Completed
Workstream 2 - HIIT sessions completed
|
551 Number of HIIT sessions
|
PRIMARY outcome
Timeframe: From the first to last exercise session, i.e. from week 0 to week 6.Population: Includes all participants that completed the programme and the type of units is the number of HIIT intervals completed. The number analysed is the total amount of planned HIIT intervals. The count of units is the number of intervals that were actually completed.
Considers the number of HIIT intervals completed compared to the theoretical number.
Outcome measures
| Measure |
High-Intensity Interval Training
n=828 Number of HIIT intervals
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Tolerability Test - Number of HIIT Intervals Completed
Workstream 1 - HIIT intervals completed
|
234 Number of HIIT intervals
|
|
Tolerability Test - Number of HIIT Intervals Completed
Workstream 2 - HIIT intervals completed
|
475 Number of HIIT intervals
|
SECONDARY outcome
Timeframe: From enrolment to completion of 12-week follow-upPopulation: The analysed population is all patients who were recruited to the programme. Adverse events were considered at each visit and exercise session.
Defined as the occurrence of any adverse or serious adverse events related to the intervention.
Outcome measures
| Measure |
High-Intensity Interval Training
n=70 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Safety Events Recorded
Workstream 1
|
3 Events
|
|
Safety Events Recorded
Workstream 2
|
9 Events
|
SECONDARY outcome
Timeframe: post-intervention follow-up, i.e. week 6.An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Outcome measures
| Measure |
High-Intensity Interval Training
n=23 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Acceptability Testing
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 29/40 Total = 44/70. 4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70. 12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70.
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Outcome measures
| Measure |
High-Intensity Interval Training
n=44 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Maximum Walking Distance
Workstream 1 baseline
|
243.8 metres
Standard Deviation 102.2
|
|
Maximum Walking Distance
Workstream 1 Post-intervention follow-up
|
365.2 metres
Standard Deviation 153.6
|
|
Maximum Walking Distance
Workstream 1 - 4-week post intervention follow-up
|
365.4 metres
Standard Deviation 172.3
|
|
Maximum Walking Distance
Workstream 1 - 12-week post intervention follow-up
|
374.2 metres
Standard Deviation 233.4
|
|
Maximum Walking Distance
Workstream 2 baseline
|
366.5 metres
Standard Deviation 201.0
|
|
Maximum Walking Distance
Workstream 2 Post-intervention follow-up
|
455.0 metres
Standard Deviation 220.8
|
|
Maximum Walking Distance
Workstream 2 - 4-week post intervention follow-up
|
450.7 metres
Standard Deviation 242.8
|
|
Maximum Walking Distance
Workstream 2 - 12-week post intervention follow-up
|
448.1 metres
Standard Deviation 240.9
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: End of programme follow-up: Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70. 4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70. 12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70.
Peak oxygen uptake assessed via cardiopulmonary exercise testing
Outcome measures
| Measure |
High-Intensity Interval Training
n=42 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Peak Oxygen Uptake
Workstream 1 - baseline VO2Peak
|
15.4 ml/kg/min
Standard Deviation 2.8
|
|
Peak Oxygen Uptake
Workstream 1 - post-intervention follow-up VO2Peak
|
15.9 ml/kg/min
Standard Deviation 3.0
|
|
Peak Oxygen Uptake
Workstream 1 - 4-week post-intervention follow-up VO2Peak
|
15.8 ml/kg/min
Standard Deviation 2.3
|
|
Peak Oxygen Uptake
Workstream 1 - 12-week post-intervention follow-up VO2Peak
|
15.3 ml/kg/min
Standard Deviation 3.1
|
|
Peak Oxygen Uptake
Workstream 2 - baseline VO2Peak
|
16.4 ml/kg/min
Standard Deviation 3.9
|
|
Peak Oxygen Uptake
Workstream 2 - post-intervention follow-up VO2Peak
|
17.1 ml/kg/min
Standard Deviation 4.3
|
|
Peak Oxygen Uptake
Workstream 2 - 4-week post-intervention follow-up VO2Peak
|
16.9 ml/kg/min
Standard Deviation 4.6
|
|
Peak Oxygen Uptake
Workstream 2 - 12-week post-intervention follow-up VO2Peak
|
17.8 ml/kg/min
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (week 6)Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70.
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Outcome measures
| Measure |
High-Intensity Interval Training
n=45 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline role physical
|
52.5 units on a scale
Standard Deviation 26.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline physical functioning
|
50.1 units on a scale
Standard Deviation 18.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up physical functioning
|
54.7 units on a scale
Standard Deviation 20.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up role physical
|
55.4 units on a scale
Standard Deviation 27.7
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline pain
|
47.9 units on a scale
Standard Deviation 13.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up pain
|
50.0 units on a scale
Standard Deviation 22.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline general health
|
46.6 units on a scale
Standard Deviation 19.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up general health
|
52.7 units on a scale
Standard Deviation 20.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline vitality
|
41.5 units on a scale
Standard Deviation 15.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up vitality
|
50.9 units on a scale
Standard Deviation 17.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline social functioning
|
76.8 units on a scale
Standard Deviation 26.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up social functioning
|
76.8 units on a scale
Standard Deviation 27.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline role emotional
|
73.3 units on a scale
Standard Deviation 30.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up role emotional
|
80.0 units on a scale
Standard Deviation 25.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline mental health
|
68.6 units on a scale
Standard Deviation 17.7
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up mental health
|
73.6 units on a scale
Standard Deviation 17.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline PCS
|
37.8 units on a scale
Standard Deviation 7.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up PCS
|
39.4 units on a scale
Standard Deviation 7.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 baseline MCS
|
49.2 units on a scale
Standard Deviation 9.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 follow-up MCS
|
51.9 units on a scale
Standard Deviation 9.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline physical functioning
|
53.3 units on a scale
Standard Deviation 19.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up physical functioning
|
56.2 units on a scale
Standard Deviation 19.1
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline role physical
|
52.9 units on a scale
Standard Deviation 23.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up role physical
|
60.8 units on a scale
Standard Deviation 24.7
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline pain
|
47.3 units on a scale
Standard Deviation 19.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up pain
|
54.1 units on a scale
Standard Deviation 22.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline general health
|
54.4 units on a scale
Standard Deviation 21.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up general health
|
54.8 units on a scale
Standard Deviation 19.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline vitality
|
53.2 units on a scale
Standard Deviation 17.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up vitality
|
55.8 units on a scale
Standard Deviation 19.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline social functioning
|
77.5 units on a scale
Standard Deviation 24.7
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up social functioning
|
75.4 units on a scale
Standard Deviation 27.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline role emotional
|
73.1 units on a scale
Standard Deviation 25.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up role emotional
|
75.6 units on a scale
Standard Deviation 25.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline mental health
|
76.7 units on a scale
Standard Deviation 14.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up mental health
|
76.7 units on a scale
Standard Deviation 19.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline PCS
|
38.5 units on a scale
Standard Deviation 7.0
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up PCS
|
40.7 units on a scale
Standard Deviation 7.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 baseline MCS
|
52.3 units on a scale
Standard Deviation 8.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 follow-up MCS
|
52 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (week 6) follow-upPopulation: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70.
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Outcome measures
| Measure |
High-Intensity Interval Training
n=45 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 baseline pain score
|
4.2 units on a scale
Standard Deviation 1.3
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 follow-up pain score
|
4.4 units on a scale
Standard Deviation 1.5
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 baseline social score
|
5.5 units on a scale
Standard Deviation 1.7
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 follow-up social score
|
5.7 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 baseline activities score
|
4.4 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 follow-up activities score
|
4.6 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 baseline symptom score
|
5.5 units on a scale
Standard Deviation 0.6
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 follow-up symptom score
|
5.8 units on a scale
Standard Deviation 0.6
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 baseline emotional score
|
5.4 units on a scale
Standard Deviation 1.6
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 follow-up emotional score
|
5.4 units on a scale
Standard Deviation 1.4
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 baseline total score
|
4.9 units on a scale
Standard Deviation 1.1
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 follow-up total score
|
5.1 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 baseline pain score
|
3.7 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 follow-up pain score
|
4.5 units on a scale
Standard Deviation 1.1
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 baseline social score
|
5.2 units on a scale
Standard Deviation 1.7
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 follow-up social score
|
5.4 units on a scale
Standard Deviation 1.8
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 baseline activities score
|
4.3 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 follow-up activities score
|
4.7 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 baseline symptom score
|
4.9 units on a scale
Standard Deviation 1.3
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 follow-up symptom score
|
5.4 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 baseline emotional score
|
5.2 units on a scale
Standard Deviation 1.3
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 follow-up emotional score
|
5.5 units on a scale
Standard Deviation 1.4
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 baseline total score
|
4.6 units on a scale
Standard Deviation 1.1
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 follow-up total score
|
5.0 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 44/70. 4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70. 12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70.
The index or ratio of the pressure in the ankle compared with the arm.
Outcome measures
| Measure |
High-Intensity Interval Training
n=45 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Ankle-Brachial Pressure Index
Workstream 1 baseline
|
0.76 Index
Standard Deviation 0.22
|
|
Ankle-Brachial Pressure Index
Workstream 1 post- intervention follow-up
|
0.78 Index
Standard Deviation 0.19
|
|
Ankle-Brachial Pressure Index
Workstream 1 - 4-week post-intervention follow-up
|
0.74 Index
Standard Deviation 0.20
|
|
Ankle-Brachial Pressure Index
Workstream 1 - 12-week post-intervention follow-up
|
0.80 Index
Standard Deviation 0.20
|
|
Ankle-Brachial Pressure Index
Workstream 2 baseline
|
0.74 Index
Standard Deviation 0.19
|
|
Ankle-Brachial Pressure Index
Workstream 2 post-intervention follow-up
|
0.76 Index
Standard Deviation 0.14
|
|
Ankle-Brachial Pressure Index
Workstream 2 - 4-week post-intervention follow-up
|
0.78 Index
Standard Deviation 0.12
|
|
Ankle-Brachial Pressure Index
Workstream 2 - 12-week post-intervention follow-up
|
0.74 Index
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: End of programme follow-up: Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70. 4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70. 12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70.
Peak power output assessed via CPET
Outcome measures
| Measure |
High-Intensity Interval Training
n=42 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Peak Power Output
Workstream 1 - baseline peak power output
|
94.9 Watts
Standard Deviation 26.1
|
|
Peak Power Output
Workstream - 1 post-intervention peak power output
|
103.7 Watts
Standard Deviation 30.4
|
|
Peak Power Output
Workstream 1 - 4-weeks post-intervention follow-up peak power output
|
98.7 Watts
Standard Deviation 23.4
|
|
Peak Power Output
Workstream 1 - 12-week post-intervention follow-up peak power output
|
102.7 Watts
Standard Deviation 30.8
|
|
Peak Power Output
Workstream 2 - baseline peak power output
|
101.6 Watts
Standard Deviation 39.4
|
|
Peak Power Output
Workstream 2 - post-intervention follow-up peak power output
|
106.0 Watts
Standard Deviation 43.0
|
|
Peak Power Output
Workstream 2 - 4-weeks post-intervention follow-up peak power output
|
112.0 Watts
Standard Deviation 44.5
|
|
Peak Power Output
Workstream 2 - 12-weeks post-intervention follow-up peak power output
|
114.1 Watts
Standard Deviation 45.5
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: Post-intervention follow-up Workstream 1; n = 15/30 Workstream 2; n = 30/40 Total = 45/70. 4-week post-intervention follow-up Workstream 1; n = 12/30 Workstream 2; n = 16/40 Total = 28/70. 12-week post-intervention follow-up Workstream 1; n =11/30 Workstream 2; n = 24/40 Total = 35/70.
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Outcome measures
| Measure |
High-Intensity Interval Training
n=45 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Pain-free Walking Distance
Workstream 1 baseline
|
114.1 metres
Standard Deviation 75.4
|
|
Pain-free Walking Distance
Workstream 1 Post-intervention follow-up
|
141.3 metres
Standard Deviation 62.4
|
|
Pain-free Walking Distance
Workstream 1 - 4-week post intervention follow-up
|
172.4 metres
Standard Deviation 103.5
|
|
Pain-free Walking Distance
Workstream 1 - 12-week post intervention follow-up
|
216.3 metres
Standard Deviation 163.2
|
|
Pain-free Walking Distance
Workstream 2 baseline
|
142.5 metres
Standard Deviation 95.5
|
|
Pain-free Walking Distance
Workstream 2 Post-intervention follow-up
|
218.6 metres
Standard Deviation 166.6
|
|
Pain-free Walking Distance
Workstream 2 - 4-week post intervention follow-up
|
212.7 metres
Standard Deviation 173.8
|
|
Pain-free Walking Distance
Workstream 2 - 12-week post intervention follow-up
|
276.0 metres
Standard Deviation 214.7
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: End of programme follow-up: Workstream 1; n = 13/30 Workstream 2; n = 29/40 Total = 42/70. 4-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 16/40 Total = 26/70. 12-week follow-up: Workstream 1; n = 9/30 Workstream 2; n = 20/40 Total = 29/70.
Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing
Outcome measures
| Measure |
High-Intensity Interval Training
n=42 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 2 - baseline VAT
|
10.0 ml/kg/min
Standard Deviation 1.9
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 1 - baseline VAT
|
9.8 ml/kg/min
Standard Deviation 1.7
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 1 - post-intervention follow-up VAT
|
10.2 ml/kg/min
Standard Deviation 1.7
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 1 - 4-week post-intervention follow-up VAT
|
10.0 ml/kg/min
Standard Deviation 1.3
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 1 - 12-week post-intervention follow-up VAT
|
9.4 ml/kg/min
Standard Deviation 1.4
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 2 - post-intervention follow-up VAT
|
10.4 ml/kg/min
Standard Deviation 2.2
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 2 - 4-week post-intervention follow-up VAT
|
9.8 ml/kg/min
Standard Deviation 2.1
|
|
Ventilatory Anaerobic Threshold (VAT)
Workstream 2 - 12-week post-intervention follow-up VAT
|
10.1 ml/kg/min
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 4 weeks (week 10) and 12 weeks (week 18) post-interventionPopulation: Only patients completing the programme and providing baseline and follow-up data are included. This comprises: 4-week follow-up: Workstream 1; n = 13/30 Workstream 2; n = 16/40 Total = 29/70. 12-week follow-up: Workstream 1; n = 11/30 Workstream 2; n = 24/40 Total = 35/70.
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Outcome measures
| Measure |
High-Intensity Interval Training
n=35 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up physical functioning
|
61.9 units on a scale
Standard Deviation 20.1
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up physical functioning
|
64.1 units on a scale
Standard Deviation 20.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up role physical
|
61.5 units on a scale
Standard Deviation 30.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up follow-up role physical
|
62.5 units on a scale
Standard Deviation 26.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up pain
|
53.2 units on a scale
Standard Deviation 19.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up pain
|
54.1 units on a scale
Standard Deviation 24.7
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up general health
|
47.4 units on a scale
Standard Deviation 13.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up general health
|
53.5 units on a scale
Standard Deviation 19.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up vitality
|
51.0 units on a scale
Standard Deviation 17.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up vitality
|
55.1 units on a scale
Standard Deviation 7.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up social functioning
|
84.6 units on a scale
Standard Deviation 20.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up social functioning
|
85.0 units on a scale
Standard Deviation 17.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up role emotional
|
80.8 units on a scale
Standard Deviation 31.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up role emotional
|
76.5 units on a scale
Standard Deviation 23.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up mental health
|
71.2 units on a scale
Standard Deviation 15.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up mental health
|
71.8 units on a scale
Standard Deviation 15.2
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4-week follow-up PCS
|
40.9 units on a scale
Standard Deviation 8.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up PCS
|
38.8 units on a scale
Standard Deviation 15.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 4 week follow-up MCS
|
51.5 units on a scale
Standard Deviation 9.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 1 - 12-week follow-up MCS
|
46.8 units on a scale
Standard Deviation 17.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up physical functioning
|
61.7 units on a scale
Standard Deviation 19.9
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up physical functioning
|
61.5 units on a scale
Standard Deviation 20.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up role physical
|
63.9 units on a scale
Standard Deviation 24.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up role physical
|
57.3 units on a scale
Standard Deviation 23.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week pain
|
55.6 units on a scale
Standard Deviation 20.3
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up pain
|
57.5 units on a scale
Standard Deviation 23.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up general health
|
54.6 units on a scale
Standard Deviation 18.1
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up general health
|
53.2 units on a scale
Standard Deviation 19.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up vitality
|
54.9 units on a scale
Standard Deviation 20.7
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12 -week follow-up vitality
|
54.8 units on a scale
Standard Deviation 22.0
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up social functioning
|
79.9 units on a scale
Standard Deviation 25.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up social functioning
|
76.5 units on a scale
Standard Deviation 27.8
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 4-week follow-up role emotional
|
77.3 units on a scale
Standard Deviation 26.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up role emotional
|
77.7 units on a scale
Standard Deviation 26.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 4-week follow-up mental health
|
78.9 units on a scale
Standard Deviation 17.4
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up mental health
|
78.0 units on a scale
Standard Deviation 18.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up PCS
|
41.7 units on a scale
Standard Deviation 7.5
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up PCS
|
41.0 units on a scale
Standard Deviation 8.6
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 4-week follow-up MCS
|
52.5 units on a scale
Standard Deviation 10.0
|
|
Quality of Life Questionnaire Short-form-36 (SF-36)
Workstream 2 - 12-week follow-up MCS
|
52.3 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.Population: Only patients completing the programme and providing follow-up data are included. This comprises: 4-week follow-up: Workstream 1; n = 13/30 Workstream 2; n = 16/40 Total = 29/70. 12-week follow-up: Workstream 1; n = 10/30 Workstream 2; n = 24/40 Total = 34/70.
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Outcome measures
| Measure |
High-Intensity Interval Training
n=34 Participants
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 4-week follow-up pain score
|
4.7 units on a scale
Standard Deviation 1.7
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 -12-week follow-up pain score
|
5.4 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 4-week follow-up social score
|
6.3 units on a scale
Standard Deviation 1.1
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 12-week follow-up social score
|
6.4 units on a scale
Standard Deviation 0.9
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 4-week follow-up activities score
|
5.2 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 12-week follow-up activities score
|
5.2 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 4-week follow-up symptom score
|
5.8 units on a scale
Standard Deviation 0.6
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 12-week follow-up symptom score
|
5.9 units on a scale
Standard Deviation 0.7
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 4-week follow-up emotional score
|
6.0 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 12-week follow-up emotional score
|
6.4 units on a scale
Standard Deviation 0.4
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 4-week total score
|
5.6 units on a scale
Standard Deviation 1.0
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 1 - 12-week follow-up total score
|
5.8 units on a scale
Standard Deviation 0.7
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 4-week follow-up pain score
|
4.8 units on a scale
Standard Deviation 1.3
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 12-week follow-up pain score
|
4.6 units on a scale
Standard Deviation 1.3
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 4-week follow-up social score
|
5.5 units on a scale
Standard Deviation 1.6
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 12-week follow-up social score
|
5.4 units on a scale
Standard Deviation 1.7
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 4-week follow-up activities score
|
4.9 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 12-week follow-up activities score
|
4.7 units on a scale
Standard Deviation 1.1
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 4-week follow-up symptom score
|
5.3 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 12-week follow-up symptom score
|
5.2 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 4-week follow-up emotional score
|
5.7 units on a scale
Standard Deviation 1.3
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 12-week follow-up emotional score
|
5.5 units on a scale
Standard Deviation 1.1
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 4-week follow-up total score
|
5.2 units on a scale
Standard Deviation 1.2
|
|
Vascular Quality of Life Questionnaire - (VascuQol)
Workstream 2 - 12-week follow-up total score
|
5.0 units on a scale
Standard Deviation 1.1
|
Adverse Events
High-Intensity Interval Training
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-Intensity Interval Training
n=70 participants at risk
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
Vascular disorders
Thrombosed popliteal aneurysm
|
1.4%
1/70 • Number of events 1 • From enrollment to 18 weeks later for each patient.
|
Other adverse events
| Measure |
High-Intensity Interval Training
n=70 participants at risk
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
|
|---|---|
|
General disorders
Post-exercise dizzines
|
8.6%
6/70 • Number of events 7 • From enrollment to 18 weeks later for each patient.
|
|
Cardiac disorders
Dull chest ache
|
1.4%
1/70 • Number of events 1 • From enrollment to 18 weeks later for each patient.
|
|
Musculoskeletal and connective tissue disorders
Back spasm
|
1.4%
1/70 • Number of events 1 • From enrollment to 18 weeks later for each patient.
|
|
General disorders
Headache
|
1.4%
1/70 • Number of events 1 • From enrollment to 18 weeks later for each patient.
|
|
Cardiac disorders
Hypertensive CPET response
|
1.4%
1/70 • Number of events 1 • From enrollment to 18 weeks later for each patient.
|
Additional Information
Dr Sean Pymer
Hull University Teaching Hospitals NHS Trust
Phone: 01482 674643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place