Trial Outcomes & Findings for Comparison of Repetitive Magnetic Stimulation and Exercise on Quadriceps Function in COPD (NCT NCT00737698)
NCT ID: NCT00737698
Last Updated: 2023-09-28
Results Overview
Quadriceps fibre cross-sectional area type II a fibres in quadriceps fibre.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-09-28
Participant Flow
There were 86 enrolled and 71 completed the study
Participant milestones
| Measure |
Exercise
Exercise
Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
|
Repetitive Magnetic Stimulation
Repetitive magnetic stimulation
Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
|
Control
No active treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
42
|
21
|
|
Overall Study
COMPLETED
|
17
|
37
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
Reasons for withdrawal
| Measure |
Exercise
Exercise
Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
|
Repetitive Magnetic Stimulation
Repetitive magnetic stimulation
Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
|
Control
No active treatment
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
3
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Comparison of Repetitive Magnetic Stimulation and Exercise on Quadriceps Function in COPD
Baseline characteristics by cohort
| Measure |
Exercise
n=17 Participants
Exercise
Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
|
Repetitive Magnetic Stimulation
n=37 Participants
Repetitive magnetic stimulation
Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
|
Control
n=17 Participants
No active treatment
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
66 years
n=107 Participants
|
67 years
n=206 Participants
|
67 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=99 Participants
|
37 participants
n=107 Participants
|
17 participants
n=206 Participants
|
71 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Per protocol analysis
Quadriceps fibre cross-sectional area type II a fibres in quadriceps fibre.
Outcome measures
| Measure |
Exercise
n=17 Participants
Exercise
Exercise: Physiotherapist-supervised exercise course (endurance and resistance exercises) for 2 hours twice a week for 8 weeks
|
Repetitive Magnetic Stimulation
n=37 Participants
Repetitive magnetic stimulation
Repetitive magnetic stimulation: Repetitive magnetic stimulation of the intramuscular branches of the femoral nerve for 3 hours twice a week for 8 weeks
|
Control
n=17 Participants
No active treatment
|
|---|---|---|---|
|
Quadriceps Fibre Size of Type IIa Fibres
|
3885 micrometers squared
Interval 3175.0 to 4985.0
|
4326 micrometers squared
Interval 3299.0 to 5237.0
|
3610 micrometers squared
Interval 3168.0 to 4487.0
|
Adverse Events
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Repetitive Magnetic Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place