Trial Outcomes & Findings for Feasibility of Home-based Preoperative Exercise in Older People (NCT NCT02895464)
NCT ID: NCT02895464
Last Updated: 2025-03-25
Results Overview
The recruitment rate is calculated by the number of participants allocated to either the exercise group or control group from the total number of eligible participants (n=66).
COMPLETED
NA
23 participants
Baseline
2025-03-25
Participant Flow
Patients scheduled for colorectal cancer surgery at Stockholm South General Hospital were informed about the study and asked to participate. The screening for inclusion was undertaken from September 2016 to June 2018 by a surgeon and nurse at the weekly colorectal cancer conferences (CRC).
There were 66 eligible participants. Of those 66, 43 declined to participate due to: they did not want to delay surgery (n=6), felt it was too much stress (n=12), additional hospital visit (n=10), already exercising (n=3), no reason given (n=10), and could not be reached (n=2).
Participant milestones
| Measure |
Exercise Group
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
|
Control Group
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
|
|---|---|---|
|
Baseline
STARTED
|
11
|
12
|
|
Baseline
COMPLETED
|
10
|
11
|
|
Baseline
NOT COMPLETED
|
1
|
1
|
|
Follow-up
STARTED
|
10
|
11
|
|
Follow-up
COMPLETED
|
10
|
11
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exercise Group
n=10 Participants
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
|
Control Group
n=11 Participants
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
83.5 years
n=10 Participants
|
74 years
n=11 Participants
|
76 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
7 Participants
n=11 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
4 Participants
n=11 Participants
|
8 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
10 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
21 Participants
n=21 Participants
|
|
Type of surgery approach
Open
|
3 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
6 Participants
n=21 Participants
|
|
Type of surgery approach
Laparoscopic
|
7 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The number of participants allocated to each group \[exercise group (n=11), control group (n=12), overall study (n=23)\] by the total number of eligible participants (n=66).
The recruitment rate is calculated by the number of participants allocated to either the exercise group or control group from the total number of eligible participants (n=66).
Outcome measures
| Measure |
Overall Study
n=66 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Recruitment Rate
Exercise
|
11 Participants
|
—
|
|
Recruitment Rate
Control
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: At the end of the intervention, after 2-4 weeksPopulation: The number of planned sessions and attended sessions.
Compliance with the exercise intervention was defined as the number of sessions attended out of planned sessions and was registered in the exercise logs by the physiotherapists in primary care. Only participants randomized to the exercise group were evaluated for this assessment.
Outcome measures
| Measure |
Overall Study
n=60 Number of exercise sessions
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=60 Number of exercise sessions
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Exercise Compliance
|
60 Number of exercise sessions
|
58 Number of exercise sessions
|
PRIMARY outcome
Timeframe: At the end of the intervention, after 2-4 weeksPatients and instructors satisfaction with the intervention measured with a survey. Instructors were not enrolled. Only participants randomized to the exercise group were evaluated for this assessment.
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=6 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Acceptability
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During the intervention, after 1-4 weeksMusculoskeletal-related events, cardiovascular episodes, falls and health care use that occurred during the exercise intervention before (pre)-surgery. Adverse events are only reported for the intervention group since the control group were a treatment as usual (TAU) group.
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Adverse Events
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgeryMeters completed, effort estimated
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=11 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Six-minute Walk
|
15 meter
Interval -29.0 to 46.0
|
-4 meter
Interval -16.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgeryInspiratory muscle strength measured with MicroRPM.
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=10 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Inspiratory Muscle Strength
|
17 cm H2O
Interval 7.0 to 25.0
|
-2 cm H2O
Interval -6.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgeryNumber of stands during 30 sec.
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=11 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Chair-stand 30-sec
|
3.5 Stands per 30 sec
Interval 0.0 to 4.0
|
1 Stands per 30 sec
Interval -0.3 to 3.3
|
SECONDARY outcome
Timeframe: Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgeryNormal walking speed was measured over 10 meters.
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=11 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Walking Speed
|
0.09 m/s
Interval 0.0 to 0.3
|
0.09 m/s
Interval -0.002 to 0.13
|
SECONDARY outcome
Timeframe: Within the first 30 days of surgeryClavien-Dindo, number of participants with at least one postoperative complication.
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=11 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Postoperative Complications
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At discharge, 2-4 weeks after baselineNumber of days admitted to the hospital
Outcome measures
| Measure |
Overall Study
n=10 Participants
Total for the exercise group and control group.
|
Attended Exercise Sessions
n=11 Participants
The total number of attended sessions in the exercise intervention.
|
|---|---|---|
|
Length of Stay
|
5 Days
Interval 4.0 to 6.0
|
6 Days
Interval 4.0 to 7.0
|
Adverse Events
Exercise Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise Group
n=10 participants at risk
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
|
Control Group
n=11 participants at risk
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
|
|---|---|---|
|
Vascular disorders
Dizziness
|
10.0%
1/10 • Number of events 2 • Three weeks
|
0.00%
0/11 • Three weeks
|
|
Musculoskeletal and connective tissue disorders
Pain
|
20.0%
2/10 • Number of events 2 • Three weeks
|
0.00%
0/11 • Three weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place