N/A
N=53
Effect of Blood Flow Restriction Resistance Exercises in COPDAE In-patient Rehabilitation
Chronic Obstructive Pulmonary Disease · Acute Exacerbation of COPD
Bottom Line
View on ClinicalTrials.gov: NCT04448236 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks — 25.9; 24.7 kgf
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood flow restriction resistance exercise (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Authority, Hong Kong
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks |
25.9; 24.7 | — |
| SECONDARY Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks |
8.5; 7 | — |
| SECONDARY Change of Hand Grip Strength in 3 Weeks |
1; 2 | — |
| SECONDARY Change of Health Related Quality of Life in 3 Weeks |
6.5; 6 | — |
| SECONDARY Average Pain Score of Each Training |
0; 0; 3.4; 0; 0; 0 | — |
| SECONDARY Reasons of Drop-out of Blood Flow Restriction Resistance Exercise |
3; 0; 2; 1; 2; 0 | — |
| SECONDARY Feasibility of BFR Exercise |
7; 1 | — |
| SECONDARY Unplanned Readmission Rate on 1 Month Post Discharge |
2; 3; 2; 1; 16; 21 | — |
| SECONDARY 6-minute Walk Test Distance Gain |
5.5; 37 | — |
| SECONDARY Acceptability of Blood Flow Restriction Resistance Exercise |
5; 10; 15; 15 | — |
Summary
This is a randomised controlled trial of the blood flow restriction resistance exercise (BFR-RE) for early rehabilitation of chronic obstructive pulmonary disease acute exacerbation (COPDAE) in the Haven of Hope Hospital.
BFR-RE was invented by Dr. Yoshiaki Sato in Japan 40 years ago. This exercise was newly introduced to the Physiotherapy Department of Haven of Hope Hospital in March, 2020 and not a routine common training in Hospital Authority. However, currently the "BFR-device" is in its 3rd generation. Under the guidance of a certified physiotherapist, a "low load intensity" can be used for resistance training to build up muscle mass and strength by applying the device over the thigh to partially limit the blood flow to the distal limb.
BFR-RE is well studied in athletes, elderlies and patients for rehabilitation after orthopaedics surgeries. A large amount of literature reveals BFR-RE with "low load intensity" shows comparable increase of muscle mass as "high load intensity" resistance training and more increase of muscle strength than those only undergoing "low load intensity" resistance training.
The objective of this study is to investigate the additional effects of 2-week BFR-RE in patients with COPDAE on top of the conventional in-patient rehabilitation training. The primary outcome is effect on localized muscle strength. The secondary outcomes include mobility function, systemic muscle strength as reflected by handgrip strength(HGS), health related quality of life, unplanned readmission to acute hospital rate within 1 month for COPDAE.
Eligibility Criteria
Inclusion Criteria
- COPD acute exacerbation (COPDAE) as the primary diagnosis for hospitalization or transfer to pulmonary wards of the Haven of Hope Hospital
- Able to walk under supervision
- Understand instruction in Cantonese and can give informed consent.
Exclusion Criteria
- Concomitant acute cardiac event
- Severe hypertension (BP > 180/100)
- History of venous thromboembolism
- History of peripheral vascular disease
- Absence of posterior tibial or dorsalis pedal pulse
- History of revascularization of the extremity
- History of lymphectomies
- Extremities with dialysis access
- Vascular grafting
- Current extremity infection
- Active malignancy
- Open fracture / soft tissue injuries
- Amputation to the lower extremity
- Expected hospitalization less than 2 weeks on admission
- Medications known to increase clotting risks
Data sourced from ClinicalTrials.gov (NCT04448236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.