Geriatric DisorderNCT01735682
Whole Body Vibration Exercise Training for Institutionalized Elderly
A study testing Whole body vibration and Conventional exercise in people with Geriatric Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- Whole body vibration and Conventional exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2012to Oct 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Functional Ambulation Category 1 to 4
- able to understand simple verbal commands
- able to tolerate intermittent physical activity for at least 45 minutes
- able to perform knee flexion >45 degree
- able to stand with or without support for 1 minute or more
Who cannot join
- peripheral vascular disease
- any symptoms associated with vestibular disorder
- any contraindications to exercise (e.g. unstable angina)
- any serious illnesses that preclude participation (e.g. cancer)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Shatin Hospital
Shatin, New Territories
Philip Chan, MSc, 852-9851-1382, cfl083@gmail.com
About this study
Official title: The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Institutionalized Elderly: a Randomized Controlled Trial
It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group.
- Conditions
- Geriatric Disorder
- Being tested
- Whole body vibration, Conventional exercise, Control
- Keywords
- older adults, exercise, balance, gait, fall, rehabilitation, vibration, muscle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationDevice
The vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively. The total exposure to the vibration stimulation is 4 minutes.
Conventional exerciseBehavioural
The conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags.
ControlBehavioural
The control treatment involves exercises of the upper limbs.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration | Experimental | This group will receive whole body vibration and conventional exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks). Receives: Device: Whole body vibration |
| Conventional exercise | Active comparator | This group will receive convention exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks). Receives: Behavioral: Conventional exercise |
| Control | Active comparator | This group will have exercise training that involve only the upper limbs (about 30 minutes per session, 3 sessions per week, for 8 consecutive weeks). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed-Up-and-Go test
It is a measure of functional mobility
Measured: week 0
Timed-up-and-go test
Measured: week 8
Secondary outcomes (17)
Berg balance scale
Measured: week 0
Berg balance scale
Measured: week 8
leg extension strength
Measured: week 0
leg extension strength
Measured: week 8
shoulder abduction strength
Measured: week 0
shoulder abduction strength
Measured: week 8
elbow flexion strength
Measured: week 0
elbow flexion strength
Measured: week 8
six minute walk test
Measured: week 0
six minute walk test
Measured: week 8
Activities-specific balance confidence scale
Measured: week 0
Activities-specific balance confidence scale
Measured: week 8
Quick DASH
A measure of upper limb function
Measured: week 0
Quick DASH
Measured: week 8
Physiological Profile Assessment: short form
Measured: week 0
Physiological Profile Assessment: short form
Measured: week 8
falls incidence
Measured: Daily from week 0 to 12 months after termination of treatment/control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Geriatric DisorderStudies 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Shatin Hospital
- Responsible party
- Principal investigator, Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
- Investigators
- Marco Pang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735682
- Sponsor's protocol ID
- HSEARS20120730001
- Status last verified
- May 2014
- First submitted
- 20 Nov 2012
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
PubMed 16372905Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
PubMed 15706558
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Body Vibration Exercise Training on Physical Functioning and Falls in Institutionalized Elderly: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01735682
- Acronym / sponsor ID
- HSEARS20120730001
- Conditions
- Geriatric Disorder
- Keywords
- older adults, exercise, balance, gait, fall, rehabilitation, vibration, muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Shatin Hospital
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 28 Nov 2012 (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.
It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration | Experimental | Device: Whole body vibrationThis group will receive whole body vibration and conventional exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks). |
| Conventional exercise | Active comparator | Behavioral: Conventional exerciseThis group will receive convention exercise training (1 hour per session, 3 sessions per week, for 8 consecutive weeks). |
| Control | Active comparator | Behavioral: ControlThis group will have exercise training that involve only the upper limbs (about 30 minutes per session, 3 sessions per week, for 8 consecutive weeks). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Functional Ambulation Category 1 to 4
- able to understand simple verbal commands
- able to tolerate intermittent physical activity for at least 45 minutes
- able to perform knee flexion >45 degree
- able to stand with or without support for 1 minute or more
Key exclusion criteria (4 listed)
- peripheral vascular disease
- any symptoms associated with vestibular disorder
- any contraindications to exercise (e.g. unstable angina)
- any serious illnesses that preclude participation (e.g. cancer)
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 |
|---|---|---|
| Whole body vibrationThe vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively. The total exposure to the vibration stimulation is 4 minutes. | Device | Whole body vibration |
| Conventional exerciseThe conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags. | Behavioural | Conventional exercise |
| ControlThe control treatment involves exercises of the upper limbs. | Behavioural | Control |
Primary outcome
Timed-Up-and-Go test
Time frame: week 0
It is a measure of functional mobility
Timed-up-and-go test
Time frame: week 8
17 secondary outcomes
Berg balance scale
Time frame: week 0
Berg balance scale
Time frame: week 8
leg extension strength
Time frame: week 0
leg extension strength
Time frame: week 8
shoulder abduction strength
Time frame: week 0
shoulder abduction strength
Time frame: week 8
elbow flexion strength
Time frame: week 0
elbow flexion strength
Time frame: week 8
six minute walk test
Time frame: week 0
six minute walk test
Time frame: week 8
Activities-specific balance confidence scale
Time frame: week 0
Activities-specific balance confidence scale
Time frame: week 8
Quick DASH
Time frame: week 0
Quick DASH
Time frame: week 8
Physiological Profile Assessment: short form
Time frame: week 0
Physiological Profile Assessment: short form
Time frame: week 8
falls incidence
Time frame: Daily from week 0 to 12 months after termination of treatment/control period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
- Background: PubMed 16372905Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
- Background: PubMed 15706558Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
Related trials for Geriatric Disorder
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 1
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Focal Seizures
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
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.
Marco Pang, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration and Conventional exercise in people with Geriatric Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 inclusion and 4 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 30 May 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 Hong Kong. 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. 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 Philip Chan, MSc (852-9851-1382, cfl083@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed-Up-and-Go test (time frame: week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01735682, which also lists 2 linked publications.
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 30 May 2014.