Condition category
Musculoskeletal Diseases
Date applied
02/10/2020
Date assigned
10/11/2020
Last edited
06/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.whpu.edu.cn/EN/

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

Publication citations

Additional files

Editorial Notes

06/11/2020: Trial’s existence confirmed by Yangtze river shipping general hospital, Wuhan brain hospital, Ethical review board.