Is the Flexi-bar exercise tool useful for combating loss of muscular strength?
| ISRCTN | ISRCTN14316668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14316668 |
| EudraCT/CTIS number | Nil Known |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | NSFHB2019 |
- Submission date
- 02/10/2020
- Registration date
- 10/11/2020
- Last edited
- 17/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Dynapenia is defined as age-related loss of muscle strength and power. It is strongly associated with a high risk of falls, poor physical performance, disability and death. Flexi-bar is a type of vibration training. It has bee used as a strength training device in recent years. The objective of this study is to investigate the effects and mechanisms of 12-week Flexi-bar training program on muscle strength and physical function in the older people with dynapenia.
Who can participate?
People aged over 65 yrs with dynapenia (age-related muscle loss) can participate in this study.
What does the study involve?
Community-dwelling seniors with dynapenia will be randomly divided into 3 equal groups, namely, Flexi-bar group, sham group and control group (no training) for 12-week Flexi-bar training. Assessments will be done before and after the intervention and 12-week follow-up.
What are the possible benefits and risks of participating?
Long-term Flexi-bar use has positive effects on muscle strength and physical function in old people. The older people with dynapenia might gain muscle strength after a 12-week Flexi-bar training. Flexi-bar is a convenient and safe training device for older people.
Where is the study run from?
This study will run in Health Service Centers in General Hospital of the Yangtze River Shipping, Wuhan (China)
When is the study starting and how long is it expected to run for?
September 2020 to December 2023
Who is funding the study?
Natural Science Foundation of Hubei Province (Project #2019CFB349)
Who is the main contact?
Dr Ning Wei (Nicole), nicole.weining@whpu.edu.cn
Contact information
Scientific
Room 309
Department of Rehabilitation Sciences
College of Health Science & Nursing
Wuhan Polytechnic University
Wuhan
430048
China
| Phone | +86 18171499135 |
|---|---|
| nicole.weining@whpu.edu.cn |
Study information
| Study design | Interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | The effect and mechanisms of Flexi-bar on muscle strength and physical performance in the older people with dynapenia |
| Study objectives | Flexi-bar can improve muscle strength and physical performance in the older people with dynapenia |
| Ethics approval(s) | Approved 29/09/2020, Yangtze river shipping general hospital, Wuhan brain hospital, Ethical review board (5 Huiji Road, Jiangan District, Wuhan, China; +862782451304; chzyykjc@163.com), ref: L20200013 |
| Health condition(s) or problem(s) studied | Dynapenia |
| Intervention | Current interventions as of 25/03/2021: The participants will be randomized to flexi-bar group, sham group and control group (no training). Training sessions (3 days/week, for 12 weeks) will be conducted at the General Hospital of Yangtze River Shipping, Wuhan. Each training session will include 10 sets of 30-second vibration. One minute of rest period will be given between training set to avoid over exertion of the participants. During training, the flexi-bar group will hold a Flexi-Bar (FLEXI-BAR®; Flexi-Sports, Germany) with shoulder flexed 90° to perform an up-and-down vibration exercise. The sham group will hold the same flexi-bar with no active vibration workout to performa same up-and-down exercise. During the training sessions, the participants will be asked to stand with knee angle of 120°. All participants will be asked to keep their lifestyle as usual. Randomization: Each recruited participant will be given an identification number by a research assistant (CL), who performed the randomization with a computer program (Research Randomizer Form www.randomizer.org/). Previous interventions: The participants will be randomized to flexi-bar group, sham group and control group (no training). A total of 20 training sessions (5 days/week, 4 weeks) will be conducted in Department of Rehabilitation of Health Service Centers. Each training session will include 10 sets of 30-second vibration. One minute of rest period will be given between training set to avoid over exertion of the participants. During training, the flexi-bar group will hold a Flexi-Bar (FLEXI-BAR®; Flexi-Sports, Germany) with shoulder flexed 90° to perform an up-and-down vibration exercise. The sham group will hold the same flexi-bar with no active vibration workout to performa same up-and-down exercise. During the training sessions, the participants will be asked to stand with knee angle of 120°. All participants will be asked to keep their lifestyle as usual. Randomization: Each recruited participant will be given an identification number by a research assistant (CL), who performed the randomization with a computer program (Research Randomizer Form www.randomizer.org/). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | FLEXI-BAR®; Flexi-Sports, Germany |
| Primary outcome measure | Current primary outcome measure as of 16/06/2021: Fitness measured using the timed-up-and-go test (TUG) at baseline, 1 day after training completion, and 12 weeks after training completion Previous primary outcome measure: Handgrip muscle strength will be measured using a hand dynamometer at baseline, after intervention and follow-up |
| Secondary outcome measures | Current secondary outcome measures as of 16/06/2021: 1. Handgrip muscle strength measured using a hand dynamometer at baseline, 1 day after training completion, and 12 weeks after training completion 2. Fitness measured using five-repetition sit-to-stand test and 10-meter walking test at baseline, 1 day after training completion, and 12 weeks after training completion 3. Levels of serum albumin and hemoglobin measured by blood test at baseline, 1 day after training completion, and 12 weeks after training completion Previous secondary outcome measures: 1. Fitness measured using timed-up-and-go test, five-repetition sit-to-stand, 10-meter walking test at baseline, after intervention and follow-up. 2. Clinical parameters (C-reactive protein, Hemoglobin, Serum albumin, Serum creatinine, Serum creatinine and Glucose) will be measured by blood test at pre and post-intervention. |
| Overall study start date | 29/09/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 114 |
| Key inclusion criteria | 1. Participants aged 65 years or above attending the Health Service Centers in General Hospital of the Yangtze River Shipping, Wuhan 2. Men and women with muscle strength less than 26kg and 18kg, respectively |
| Key exclusion criteria | 1. Severe heart problem 2. Neuro-degenerative diseases 3. Vestibular disorders 4. Cognitive impairment 5. Severe osteoporosis 6. Visual impairment 7. Mental diseases |
| Date of first enrolment | 06/09/2021 |
| Date of final enrolment | 01/03/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Jiangan District
Wuhan
430010
China
Sponsor information
University/education
Department of Rehabilitation Sciences
College of Health Science & Nursing
Wuhan
430048
China
| Phone | +86 83956726 |
|---|---|
| kjtysq@hubei.gov.cn | |
| Website | http://www.whpu.edu.cn/EN/ |
"ROR" |
https://ror.org/05w0e5j23 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| 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 high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
17/06/2021: Internal review.
16/06/2021: The primary outcome measure and secondary outcome measures have been updated.
03/06/2021: The recruitment start date has been changed from 01/03/2021 to 06/09/2021.
25/03/2021: Due to current public health guidance, recruitment for this study has been paused and The following changes have been made:
1. The interventions have been updated.
2. The plain English summary has been updated to reflect the changes above.
06/11/2020: Trial’s existence confirmed by Yangtze river shipping general hospital, Wuhan brain hospital, Ethical review board.
