Sarcopenia;NCT02090192
Effects of Whole-body Vibration in the Frail Elderly
A study testing WBV training and PRT training in people with Sarcopenia; and Osteoporosis, run by Li Zhang at 1 site in China.
Trial summary
Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients. Design: Randomized controlled trial. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia;, Osteoporosis
- What is being tested?
- WBV training and PRT training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥75 years old
- Fried Frailty Criteria
- Mini Mental State Examination score ≥18
Who cannot join
- Recent fractures (≤6 months)
- Gallbladder or kidney stones
- Malignancies
- Rheumatic arthritis
- Epilepsy
- Serious heart sicknesses or an implant, and bypass stent or cardiac pacemaker
- Any diseases to be associated with a life expectancy of less than 12 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Rehabilitation Department, Nanlou, Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Chunhua Li, Bachelor, 8610-66875462, 18601224462@163.com
About this study
Official title: Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly
Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.
Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.
Read more
Interventions: All eligible subjects were randomly assigned to 4 groups:
(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.
Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.
Study hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail elderly.
- Conditions
- Sarcopenia;, Osteoporosis
- Being tested
- WBV training, PRT training
- Keywords
- Whole-body vibration;, Frail Elderly;, Blood flow;, Bone density, Mobility;, Balance;, Muscle strength;, Lower Extremity;, Musculoskeletal System;, Health Status;, Exercise;, Mechanical Oscillation
- Medical subject headings
- Sarcopenia, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBV trainingProcedure or surgery
PRT trainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| WBV training | Experimental | Whole-body vibration training was performed on a commercial Galileo machine (Germany). Participants were required to stand on the moveable rectangular platform and positioned their feet at an equal and standardized distance from the axis of rotation so that the vertical vibration amplitude was 1-3 mm. The frequency was set at 6-26 Hz. The vibration protocol consisted of four to five bouts (60 seconds for each bout), and three to five times a week for 12 weeks. The positions taken by the subjects differed according to their function. Participants who could stand independently were instructed to adopt a "partial squat" position with slight flexion at the hips, knees, and ankle joints to damp the vibrations approximately at the pelvic level. Receives: Procedure: WBV training |
| WBV+ PRT training | Experimental | Not described Receives: Procedure: WBV training; Procedure: PRT training |
| PRT training | Active comparator | Not described Receives: Procedure: PRT training |
| Control group | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the common femoral artery's blood flow from Baseline to 60min post-WBV
Measured: 60min post-WBV
Change of lower extremities muscle strength from Baseline to 3 month post-WBV
Measured: 3 month post-WBV
Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV
Measured: 3 month post-WBV
Change of 30-second chair stand test from Baseline to 3 month post-WBV
Measured: 3 month post-WBV
Change of balance function from Baseline to 3 month post-WBV
Measured: 3 month post-WBV
Change of balance confidence from Baseline to 3 month post-WBV
Measured: 3 month post-WBV
Change of bone density from Baseline to 6 month post-WBV
Measured: 6 month post-WBV
Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
Measured: 6 month post-WBV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia;Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Zhang, Chinese PLA General Hospital
- Investigators
- Changshui Weng, Bachelor, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090192
- Sponsor's protocol ID
- ChinaPLAGH-2013FC3009
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Whole-body Vibration on Mobility, Muscle Strength, Bone and General Health Status in the Frail Elderly
- ClinicalTrials.gov ID
- NCT02090192
- Acronym / sponsor ID
- ChinaPLAGH-2013FC3009
- Conditions
- Sarcopenia;, Osteoporosis
- Keywords
- Whole-body vibration;, Frail Elderly;, Blood flow;, Bone density, Mobility;, Balance;, Muscle strength;, Lower Extremity;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Li ZhangUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To study the acute and chronic effects of whole-body vibration (WBV) exercises on the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status, and its feasibility as an intervention in frail elderly patients.
Design: Randomized controlled trial. Subjects: The frail older persons meeting the Fried Frailty Criteria.
Interventions: All eligible subjects were randomly assigned to 4 groups:
(1) WBV group: Subjects received a whole-body vibration exercise alone; (2) Progressive resistance training (PRT) group: Subjects received progressive resistance training; (3) WBV+ PRT group: Subjects received the whole-body vibration and progressive resistance training; (4) Control group: Subjects received no intervention/training. The periods of intervention are 12 weeks.
Main measures: The lower extremities blood flow (the diameters and red blood cell velocity of the common femoral artery), timed up and go test, 30-second chair stand test, five times sit to stand test, lower extremities muscle strength, balance function, balance confidence, bone density, and general health status was assessed at the beginning of the study, at instant, 12 weeks and 24 month after the intervention.
Study hypothesis: Whole-body vibration exercise is a safe and effective method that can improve the lower extremity blood flow, mobility function, balance, muscle strength, bone density, and general health status in the frail elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WBV training | Experimental | Procedure: WBV trainingWhole-body vibration training was performed on a commercial Galileo machine (Germany). Participants were required to stand on the moveable rectangular platform and positioned their feet at an equal and standardized distance from the axis of rotation so that the vertical vibration amplitude was 1-3 mm. The frequency was set at 6-26 Hz. The vibration protocol consisted of four to five bouts (60 seconds for each bout), and three to five times a week for 12 weeks. The positions taken by the subjects differed according to their function. Participants who could stand independently were instructed to adopt a "partial squat" position with slight flexion at the hips, knees, and ankle joints to damp the vibrations approximately at the pelvic level. |
| WBV+ PRT training | Experimental | Procedure: WBV training, Procedure: PRT training |
| PRT training | Active comparator | Procedure: PRT training |
| Control group | Placebo comparator | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥75 years old
- Fried Frailty Criteria
- Mini Mental State Examination score ≥18
Key exclusion criteria (7 listed)
- Recent fractures (≤6 months)
- Gallbladder or kidney stones
- Malignancies
- Rheumatic arthritis
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WBV training | Procedure or surgery | WBV training, WBV+ PRT training |
| PRT training | Procedure or surgery | PRT training, WBV+ PRT training |
Primary outcome
Change of the common femoral artery's blood flow from Baseline to 60min post-WBV
Time frame: 60min post-WBV
Change of lower extremities muscle strength from Baseline to 3 month post-WBV
Time frame: 3 month post-WBV
Change of "timed up and go" test (TUGT) from Baseline to 3 month post-WBV
Time frame: 3 month post-WBV
Change of 30-second chair stand test from Baseline to 3 month post-WBV
Time frame: 3 month post-WBV
Change of balance function from Baseline to 3 month post-WBV
Time frame: 3 month post-WBV
Change of balance confidence from Baseline to 3 month post-WBV
Time frame: 3 month post-WBV
Change of bone density from Baseline to 6 month post-WBV
Time frame: 6 month post-WBV
Change of general health status (SF-12 score) from Baseline to 6 month post-WBV
Time frame: 6 month post-WBV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changshui Weng, Bachelor study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WBV training and PRT training in people with Sarcopenia; and Osteoporosis, run by Li Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Doctor (8610-66876335, zhangli781230@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the common femoral artery's blood flow from Baseline to 60min post-WBV (time frame: 60min post-WBV). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.