Plain English Summary
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 4-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 4-week Flexi-bar training. Assessments will be done before and after the intervention and 4-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 4-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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ning Wei
ORCID ID
Contact details
Room 309
Department of Rehabilitation Sciences
College of Health Science & Nursing
Wuhan Polytechnic University
Wuhan
430048
China
+86 18171499135
nicole.weining@whpu.edu.cn
Additional identifiers
EudraCT number
Nil Known
ClinicalTrials.gov number
Nil Known
Protocol/serial number
NSFHB2019
Study information
Scientific title
The effect and mechanisms of Flexi-bar on muscle strength and physical performance in the older people with dynapenia
Acronym
Study hypothesis
Flexi-bar can improve muscle strength and physical performance in the older people with dynapenia
Ethics approval
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
Study design
Interventional single-blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Dynapenia
Intervention
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
Phase
Phase III/IV
Drug names
FLEXI-BAR®; Flexi-Sports, Germany
Primary outcome measure
Handgrip muscle strength will be measured using a hand dynamometer at baseline, after intervention and follow-up
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 trial start date
29/09/2020
Overall trial end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Other
Age group
Senior
Gender
Both
Target number of participants
114
Participant 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
Recruitment start date
01/03/2021
Recruitment end date
01/03/2022
Locations
Countries of recruitment
China
Trial participating centre
General Hospital of the Yangtze River Shipping
1 Huiji Road
Jiangan District
Wuhan
430010
China
Sponsor information
Organisation
Wuhan Polytechnic University
Sponsor details
Department of Rehabilitation Sciences
College of Health Science & Nursing
Wuhan
430048
China
+86 83956726
kjtysq@hubei.gov.cn
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Natural Science Foundation of Hubei Province (Project #2019CFB349)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
31/12/2024
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list