Is low intensity resistance training combined with blood flow restriction beneficial to the rehabilitation of patients with knee osteoarthritis?
| ISRCTN | ISRCTN51633853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51633853 |
- Submission date
- 12/05/2022
- Registration date
- 16/05/2022
- Last edited
- 09/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis causes the cartilage in your knee joint to thin and the surfaces of the joint to become rougher, which means that the knee doesn't move as smoothly as it should, and it might feel painful and stiff.
Older people with knee OA usually experience challenges in performing vital independence tasks compared to those without OA. Hence, improving muscle strength and promoting physical function recovery is an important goal of knee OA rehabilitation.
Resistance exercise is a traditional method to improve muscle mass and muscle strength, Nevertheless, the capacity to tolerate the high mechanical stresses directed onto the joints during heavy resistance training varies among individuals. A combination low load resistance training and blood flow restriction (BFR) could elicit parallel impacts as high load resistance training, which has recently led to its frequent use in the rehabilitation of knee OA. Additionally, a study revealed that single-leg BFR training effectively improved the muscle strength of the contralateral limb in healthy adults, known as the crossover effect. This event might result from the systemic circulation of myogenic-related hormones. This provides a new idea for sports rehabilitation of patients with unilateral knee OA. Nonetheless, the effect of unilateral limb exercise on serum myogenesis-related hormones in patients with knee OA remains unclear.
Our previous study demonstrated that BFR training promotes the production of muscle growth-related hormones in healthy adults. Therefore, this study aims to elucidate the effects of BFR with single-leg low load resistance exercise and high load resistance exercise on insulin-like growth factor-1, serum growth hormone, and testosterone in patients with unilateral knee OA. The findings will provide the theoretical basis to assist researchers and physical therapists in developing a more scientific exercise strategy.
Who can participate?
Female patients aged 40 - 70 years with knee OA in one knee.
What does the study involve?
The study included a survey of participants' maximum muscle strength and hormonal responses to three different exercises.
What are the possible benefits and risks of participating?
The benefits of participation can obtain more effective exercise rehabilitation prescriptions. The risk of participation is the possibility of muscle soreness after exercise.
Where is the study run from?
Qingdao Haici Hospital (China)
When is the study starting and how long is it expected to run for?
May 2022 to July 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Junguo Wang, wangjunguo7765@163.com
Contact information
Scientific
No. 4, Renmin Road
Qingdao
Qingdao
266033
China
 ORCID ID |
0000-0003-1736-6570 |
|---|---|
| Phone | +86 15731114483 |
| wangjunguo7765@163.com |
Study information
| Study design | Single-blind observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | School |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effects of low load resistance training with blood flow restriction on serum growth hormone, insulin-like growth factor-1, and testosterone in patients with mild to moderate unilateral knee osteoarthritis (OA) |
| Study acronym | BFRKOA |
| Study objectives | Myogenesis-related hormones in women with unilateral knee OA could be increased by high load resistance exercise and low load resistance exercise with BFR on unaffected limb. |
| Ethics approval(s) | Approved 02/05/2022, The Medical Ethics Committee of The Affiliated Qingdao Hiser Hospital (Qingdao Hospital of Traditional Chinese Medicine, No. 4, Renmin Road, Qingdao, Shandong, China; +8615901569205; qdhaiciwenhua@126.com), ref: 2022-HYJ-247 |
| Health condition(s) or problem(s) studied | Female patients with unilateral knee osteoarthritis |
| Intervention | This study will recruit 18 female patients with mild to moderate unilateral knee OA, which was then followed by randomly conducting three resistance exercise tests by drawing lots: 1. A 30% 1-repetition maximum (1-RM) resistance exercise with BFR of 70% arterial occlusive pressure (AOP) (BFR group) 2. A 70% 1-RM resistance exercise without BFR (RES group) 3. A 30% 1-RM resistance exercise without BFR (CON group) |
| Intervention type | Behavioural |
| Primary outcome measure | Blood lactate (BLA), IGF-1, GH and testosterone levels will be tested at 4-time points using blood test: before exercise, immediately after exercise, 15 minutes after exercise, and 30 minutes after exercise. |
| Secondary outcome measures | Heart rate measured using heart rate band during exercise |
| Overall study start date | 12/05/2022 |
| Completion date | 25/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Currently experiencing objective functional limitations 2. Female aged between 40 and 70 years old 3. Symptomatic unilateral knee OA 4. Not participating in any regular resistance training. |
| Key exclusion criteria | 1. Health status contradicted the use of a tourniquet 2. Currently suffering from peripheral vascular disorders or any condition contradicting subjecting them to exercise training 3. High blood pressure defined by a diastolic blood pressure >100 mm Hg or resting systolic blood pressure >160 or <100 mm Hg |
| Date of first enrolment | 25/05/2022 |
| Date of final enrolment | 24/06/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Qingdao
066033
China
Sponsor information
Hospital/treatment centre
No. 4
Renmin Road
Qingdao
266033
China
| Phone | +8618203218267 |
|---|---|
| 100888@shengda.edu.cn |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 25/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/05/2022 | No | No | ||
| Results article | 14/10/2022 | 09/07/2024 | Yes | No |
Additional files
Editorial Notes
09/07/2024: Publication reference and total final enrolment added.
13/05/2022: Trial's existence confirmed.
