Trial Outcomes & Findings for Effect of Blood Flow Restriction Resistance Exercises in COPDAE In-patient Rehabilitation (NCT NCT04448236)
NCT ID: NCT04448236
Last Updated: 2024-06-17
Results Overview
To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length. Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
baseline and 3 weeks (after 10-12 sessions of training)
Results posted on
2024-06-17
Participant Flow
Participant milestones
| Measure |
Blood Flow Restriction Resistance Exercise Intervention Group
The participants will have the standardised 2 week resistance training with "Blood flow restriction-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BFR-RE Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.9 year
STANDARD_DEVIATION 11.9 • n=20 Participants
|
77.4 year
STANDARD_DEVIATION 8.9 • n=25 Participants
|
76.3 year
STANDARD_DEVIATION 10.1 • n=45 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=20 Participants
|
24 Participants
n=25 Participants
|
43 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hong Kong
|
20 participants
n=20 Participants
|
25 participants
n=25 Participants
|
45 participants
n=45 Participants
|
|
body mass index (BMI)
|
19 kg/m^2
STANDARD_DEVIATION 3.1 • n=20 Participants
|
19.8 kg/m^2
STANDARD_DEVIATION 3 • n=25 Participants
|
19.4 kg/m^2
STANDARD_DEVIATION 3 • n=45 Participants
|
|
Body mass index, obstruction, dyspnea, exercise (BODE) index
|
5 units on a scale
n=20 Participants
|
5 units on a scale
n=25 Participants
|
5 units on a scale
n=45 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 weeks (after 10-12 sessions of training)To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length. Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg.
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks
|
25.9 kgf
Interval 21.3 to 30.3
|
24.7 kgf
Interval 16.6 to 35.1
|
SECONDARY outcome
Timeframe: baseline and 3 weeks (after 10-12 sessions of training)SPPB is the sum of the points from the following 3 measures, high the point, better performance * Time needed to walk 4m distance: less than 4.82s=4 points, 4.82-6.2s=3 points, 6.21-8.7s=2 points, \>8.7s=1 point; if unable to do the walk=0 point * Balance test: can hold side by side stand 10s= 1 point; semi-tandem stand 10s=1 point; tandem stand 10s=2 point; tandem stand 3-9.99s=1 point; if unable to do the stand=0 point * Repeated chair stands test:; Participant unable to complete 5 chair stands or completes stands in \>60s =0 point; If chair stand time is 16.70s or more= 1 point; If chair stand time is 13.70 to 16.69s = 2 points; If chair stand time is 11.20 to 13.69s=3 points; If chair stand time is 11.19s or less= 4 points Minimum score=0 Maximum score=12(best performance)
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks
|
8.5 score on a scale
Interval 6.3 to 10.8
|
7 score on a scale
Interval 5.0 to 8.5
|
SECONDARY outcome
Timeframe: baseline and 3 weeks (after 10-12 sessions of training)a non-invasive marker of systemic skeletal muscle strength and function, is assessed by handheld grip dynamometer of dominant hand
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Change of Hand Grip Strength in 3 Weeks
|
1 kg
Interval 0.0 to 2.0
|
2 kg
Interval 0.0 to 5.5
|
SECONDARY outcome
Timeframe: baseline and 3 weeks (after 10-12 sessions of training)Self-administered Chinese version of Chronic obstructive pulmonary disease(COPD) assessment test (CAT) It contains 8 questions and 6 points each (0 to 5). Higher score means worse health status. The Minimal clinical important difference of CAT score was 2 to 3. Minimum score=0 Maximum score=40 (worst health status)
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Change of Health Related Quality of Life in 3 Weeks
|
6.5 units on a scale
Interval 0.3 to 15.0
|
6 units on a scale
Interval 2.0 to 12.5
|
SECONDARY outcome
Timeframe: pain score before, immediate and 5-minute post exercise;Visual analog scale (0-10) for before, immediate and 5-minute post exercise. least pain=0 ; most severe pain=10
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Average Pain Score of Each Training
Before training
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Pain Score of Each Training
Immediate after training
|
3.4 score on a scale
Interval 1.3 to 5.4
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Pain Score of Each Training
5 mins after training
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: baseline to 3 weeks (after 10-12 sessions of training)Examination the reasons of drop-out in those discontinuing the training
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=7 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=1 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Reasons of Drop-out of Blood Flow Restriction Resistance Exercise
Due to contact contact precaution requirement
|
3 Participants
|
0 Participants
|
|
Reasons of Drop-out of Blood Flow Restriction Resistance Exercise
Due to hospitalization less than 2 weeks
|
2 Participants
|
1 Participants
|
|
Reasons of Drop-out of Blood Flow Restriction Resistance Exercise
Due to failure to complete training
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and 3 weeks (after 10-12 sessions of training)Examination of drop-out rate
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Feasibility of BFR Exercise
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 month after the discharge of patients in the studyUnplanned readmission rate within 1 month of discharge for Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE)
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Unplanned Readmission Rate on 1 Month Post Discharge
COPDAE related
|
2 Participants
|
1 Participants
|
|
Unplanned Readmission Rate on 1 Month Post Discharge
Not COPDAE related
|
2 Participants
|
3 Participants
|
|
Unplanned Readmission Rate on 1 Month Post Discharge
No admission
|
16 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: baseline and 3 weeks (after 10-12 sessions of training)the distance can achieved in 6-minute walk test
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
6-minute Walk Test Distance Gain
|
5.5 m
Interval -24.5 to 55.8
|
37 m
Interval 17.5 to 68.5
|
SECONDARY outcome
Timeframe: Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training)Measure the patient's acceptance by a 5-point categorical scale after the whole program. 1=very dislike, 2=dislike,3=no comment, 4= like, 5=very like Lowest score=1 Highest score=5(Higher score means better acceptance)
Outcome measures
| Measure |
Blood Flow Restriction Resistance Exercise (BFR-RE) Intervention Group
n=20 Participants
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 Participants
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Acceptability of Blood Flow Restriction Resistance Exercise
Very dislike / dislike / no comment
|
5 Participants
|
10 Participants
|
|
Acceptability of Blood Flow Restriction Resistance Exercise
like / very like
|
15 Participants
|
15 Participants
|
Adverse Events
BFR-RE Intervention Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BFR-RE Intervention Group
n=20 participants at risk
The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP)
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
|
Control Group
n=25 participants at risk
Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device".
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD acute exacerbation or hospital acquired infections
|
40.0%
8/20 • Number of events 8 • 1month
acute exacerbation or hospital acquired infections
|
16.0%
4/25 • Number of events 4 • 1month
acute exacerbation or hospital acquired infections
|
|
Musculoskeletal and connective tissue disorders
Others
|
10.0%
2/20 • Number of events 2 • 1month
acute exacerbation or hospital acquired infections
|
0.00%
0/25 • 1month
acute exacerbation or hospital acquired infections
|
|
Psychiatric disorders
insomnia
|
5.0%
1/20 • Number of events 1 • 1month
acute exacerbation or hospital acquired infections
|
0.00%
0/25 • 1month
acute exacerbation or hospital acquired infections
|
Additional Information
Dr. Lau Chung Wai
Haven of Hope hospital, Hospital Authority
Phone: 27038888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place