Condition category
Musculoskeletal Diseases
Date applied
13/01/2017
Date assigned
16/01/2017
Last edited
18/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Sarcopenia is a term used to describe the gradual loss of muscle mass and strength with age. Over time, this can lead to problems with balance, gait (the way a person walks) and overall ability to perform tasks of daily living. Exercise training has been proven to be effective at improving the symptoms of sarcopenia. In the last ten years, a new style of training called whole-body vibration (WBV) has been reported as an effective approach to improve the physical condition of healthy older adults. The effects of WBV on those with sarcopenia are unknown however. The aim of this study is to look at three regimes of WBV to find out which is most effective for improving muscle size and strength.

Who can participate?
Adults aged 65 years and over with sarcopenia.

What does the study involve?
Participants are randomly allocated to one of four groups. Those in the first three groups receive whole-body vibration training over a course of 36 sessions, each at a different frequency (the higher the frequency, the more muscle activity there is). Those in the first group receive low frequency training, those in the second receive medium frequency training and those in the third group receive high frequency training. The training sessions involve four sets (periods of training) and last for around 20 minutes. They involve standing on the WBV platform for between 60 seconds (for the high frequency group) and 180 seconds (for the low frequency group) with bent knees, five minute rests between each set. Participants in the final group continue as normal and take part in no addition exercise. At the start of the study and then again after 6, 12, 18 and 24 weeks, participants are assessed to find out if their muscle mass, strength and physical performance have changed.

What are the possible benefits and risks of participating?
Participants who are allocated to one of the training groups benefit from receiving whole body vibration training and all participants benefit from receiving a free health consultation. There are no notable risks involved with participating in this study.

Where is the study run from?
Lek Yuen Health Centre (Hong Kong)

When is the study starting and how long is it expected to run for?
January 2010 to December 2015

Who is funding the study?
Hong Kong Government Health Services Research Fund (Hong Kong)

Who is the main contact?
Dr Ning Wei

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ning Wei

ORCID ID

http://orcid.org/0000-0002-7827-375X

Contact details

Jin Di Ge Lin Chuan An 4-1-2801
South Jin Yin Street
Dongxi District
Wuhan
430048
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CSR524

Study information

Scientific title

The effects and mechanisms of whole body vibration training on muscle, balance and physical performance in community dwelling individuals with sarcopenia

Acronym

Study hypothesis

1. The WBV exercise is effective for training muscle size, strength and mobility in participants with sarcopenia
2. Different vibration frequencies would affect the muscle performance and physical condition in participants with sarcopenia
3. The changes associated with WBV training could be maintained for 3 months after cessation of training
4. There is an effect of WBV exercise on the voluntary activation of quadriceps muscle

Ethics approval

1. Department of Health of HKSAR government, 02/03/2011 ref: CSR524
2. Department of RS of PolyU, 19/06/2013

Study design

Four-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Sarcopenia

Intervention

Participants are randomly allocated to one of four groups.

Low-frequency group: Participants receive whole body vibration training with 20Hz and 4mm for 720s per session.

Medium-frequency group: Participants receive whole body vibration training with 40Hz and 4mm for 360s per session.

High-frequency group: Participants receive whole body vibration training with 60Hz and 4mm for 240s per session.

Control group: Participants receive no extra exercise.

One session of WBV training is consisted of four sets. There is a five-minute rest time after each set, which means 15 minutes rest in total. The session therefore lasts for approximately 20 minutes. During the training, the participants only stand on the WBV platform with knees flexed at 60 degrees. No extra exercises are performed.

The study consists of 36 training sessions. All assessments except twitch interpolation test are conducted at baseline, mid-intervention (6 weeks of WBV), post-intervention (12 weeks of WBV), 6 and 12 weeks after cessation of training. Twitch interpolation is only conducted at baseline and post-intervention.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Muscle mass (cross-sectional area of vastus medialis) was measured by ultrasound at baseline, 6 (18 training sessions), 12 (36 training sessions), 18 and 24 weeks
2. Muscle strength (peak torque of knee extension) was measured by Cybex with isokinetic (180 and 60 degrees per second) and isometric (knee flexed at 90 degrees) contractions at baseline, 6 (18 training sessions), 12 (36 training sessions), 18 and 24 weeks
3. Physical performance was measured by five-repetition sit-to-stand, timed-up-and-go test and 10-meter walking test at baseline, 6 (18 training sessions), 12 (36 training sessions), 18 and 24 weeks

Secondary outcome measures

1. Proprioception was measured by knee joint repositioning test at baseline, 6 (18 training sessions), 12 (36 training sessions), 18 and 24 weeks
2. Balance was measured by tandem, one-leg stand with eyes open and closed at baseline, 6 (18 training sessions), 12 (36 training sessions), 18 and 24 weeks
3. Voluntary activation was measured by twitch interpolation test at baseline and 12 weeks (36 training sessions)

Overall trial start date

08/01/2010

Overall trial end date

30/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 65 years and over
2. Skeletal mass index less than 8.87kg/m2 and 6.42kg/m2

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Participants with metal implants
2. Severe heart problem
3. Neurodegenerative diseases
4. Peripheral vascular disease
5. Vestibular disorders
6. Severe osteoporosis with fractures within one year prior to the study

Recruitment start date

08/01/2012

Recruitment end date

30/06/2015

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Lek Yuen Health Centre
9 Lek Yuen Street
Shatin
999077
Hong Kong

Sponsor information

Organisation

The Hong Kong Polytechnic University

Sponsor details

STS 828
Department of Hong Kong Polytechnic University
Kowloon
Kowloon
999077
Hong Kong

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Hong Kong Government Health Services Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from 11902302r@connect.polyu.hk

Intention to publish date

31/08/2016

Participant level data

Available on request

Basic results (scientific)

Publication list

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27578535

Publication citations

Additional files

Editorial Notes

18/07/2017: Internal edit.