FallsPhase 4VAREXNCT01523600
Whole Body Vibration Training Among Older People Using Sheltered Housing
A Phase 4 study testing Whole body vibration training and Wellness group in people with Falls and Physical Performance, run by UKK Institute at 4 sites in Finland.
Trial summary
The purpose of this randomised (double-blind) controlled exercise intervention trial is to determine whether the whole body vibration (WBV) training can effectively improve physical functioning of older people living in or regularly using services of sheltered housing, reduce their fear of falling, and prevent… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls, Physical Performance, Fear of Falling
- What is being tested?
- Whole body vibration training and Wellness group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesFinland
- Study dates
- Oct 2011to Dec 2016
- Phase
- Phase 4
- 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
- lives in sheltered housing or uses regularly services provided by sheltered housing
- ambulatory, able to walk independently with or without a walking aid
- Mini Mental State Examination (MSSE) points 16 or more
Who cannot join
- knee or hip prosthesis
- osteosynthetic material in lower limbs
- stiffening operation of the spinal column
- cardiac pacemaker
- recent fracture (< 1 yr for lower limb or spinal fractures, < ½ yr for upper limb fractures)
- recent major surgical operation
Show all 14Show fewer
- acute thrombosis or its high risk
- acute musculoskeletal inflammation
- gall or bladder stones
- problematic hernia
- unstable cardiovascular or other systematic disease
- tumor
- diabetic neuropathy
- strong vertigo
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Kaukaharjun Seniorikeskus
Tampere
Kuuselan Seniorikeskus
Tampere
Tammenlehvä-keskus
Tampere
Viola-koti
Tampere
About this study
Official title: Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing
The purpose of this randomised (double-blind) controlled exercise intervention trial is to determine whether the whole body vibration (WBV) training can effectively improve physical functioning of older people living in or regularly using services of sheltered housing, reduce their fear of falling, and prevent falling. The study comprises a 10-week training period and a 10-month follow-up period.
- Conditions
- Falls, Physical Performance, Fear of Falling
- Being tested
- Whole body vibration training, Wellness group
- Keywords
- whole body vibration, physical functioning, falls, older people, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration trainingBehavioural
Also called Galileo Med M Plus
The intervention comprises a 10-week individually supervised, progressive WBV training done twice a week on a side-alternating device with simultaneous body transferring and slight squatting exercises. At the week one, the duration of a single training bout is 1 x 1 min, and the number of 1 min bouts is weekly increased by one until five bouts is reached. During weeks 4 - 10, the training comprises 5 x 1 min bouts with 1 min rest periods between. During weeks 1 to 3, vibration frequencies are 12 and 18 Hz, which are used alternately. Thereafter, also 26 Hz may be used instead of 18 Hz. In addition, the amplitude of vibration is increased progressively according to a specified protocol. A detailed training diary is kept.
Wellness groupBehavioural
The intervention comprises a 10-week supervised group training done once a week with the focus on stretching and flexibility exercises done mostly in a sitting position. The duration of a single training session is 45 minutes. A training diary is kept.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration training | Experimental | Not described Receives: Behavioral: Whole body vibration training |
| Wellness group | Active comparator | Not described Receives: Behavioral: Wellness group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls
Participants keep fall diaries on daily basis and mail the diaries to the investigators in every month. In case of a reported fall, the investigator contacts the participant and enquires the details of the fall.
Measured: One year
Secondary outcomes (2)
Physical functioning
The standard Short Physical Performance Battery (SPPB) is used for the assessment of participant's balance, walking speed and chair rising time at the baseline, after the 10 week training and after the subsequent 10 month follow-up.In addition, 4-m maximal walking speed , Timed Up and Go (TUG) test and grip strength are assessed at the same time points.
Measured: 10 weeks and one year
Fear of falling
The Falls Efficacy Scale (FES-I)is used for the assessment of perceived fear of falling at the baseline, after 10 week training and after the subsequent 10-month follow-up.
Measured: 10 weeks and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionDec 2016 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education and Culture, Finland, Pirkanmaa Hospital District
- Responsible party
- Principal investigator, Harri Sievanen, UKK Institute
- Investigators
- Harri Sievanen, ScD, Study director, The UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523600
- Sponsor's protocol ID
- 138,04
- Other IDs
- R11122
- Acronym
- VAREX
- Status last verified
- May 2016
- First submitted
- 27 Jan 2012
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing
- ClinicalTrials.gov ID
- NCT01523600
- Acronym / sponsor ID
- VAREX / 138,04
- Conditions
- Falls, Physical Performance, Fear of Falling
- Keywords
- whole body vibration, physical functioning, falls, older people, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 130 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Ministry of Education and Culture, Finland, Pirkanmaa Hospital District
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Feb 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.
The purpose of this randomised (double-blind) controlled exercise intervention trial is to determine whether the whole body vibration (WBV) training can effectively improve physical functioning of older people living in or regularly using services of sheltered housing, reduce their fear of falling, and prevent falling. The study comprises a 10-week training period and a 10-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration training | Experimental | Behavioral: Whole body vibration training |
| Wellness group | Active comparator | Behavioral: Wellness group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- lives in sheltered housing or uses regularly services provided by sheltered housing
- ambulatory, able to walk independently with or without a walking aid
- Mini Mental State Examination (MSSE) points 16 or more
Key exclusion criteria (14 listed)
- knee or hip prosthesis
- osteosynthetic material in lower limbs
- stiffening operation of the spinal column
- cardiac pacemaker
- recent fracture (< 1 yr for lower limb or spinal fractures, < ½ yr for upper limb fractures)
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 vibration trainingAlso: Galileo Med M PlusThe intervention comprises a 10-week individually supervised, progressive WBV training done twice a week on a side-alternating device with simultaneous body transferring and slight squatting exercises. At the week one, the duration of a single training bout is 1 x 1 min, and the number of 1 min bouts is weekly increased by one until five bouts is reached. During weeks 4 - 10, the training comprises 5 x 1 min bouts with 1 min rest periods between. During weeks 1 to 3, vibration frequencies are 12 and 18 Hz, which are used alternately. Thereafter, also 26 Hz may be used instead of 18 Hz. In addition, the amplitude of vibration is increased progressively according to a specified protocol. A detailed training diary is kept. | Behavioural | Whole body vibration training |
| Wellness groupThe intervention comprises a 10-week supervised group training done once a week with the focus on stretching and flexibility exercises done mostly in a sitting position. The duration of a single training session is 45 minutes. A training diary is kept. | Behavioural | Wellness group |
Primary outcome
Number of falls
Time frame: One year
Participants keep fall diaries on daily basis and mail the diaries to the investigators in every month. In case of a reported fall, the investigator contacts the participant and enquires the details of the fall.
2 secondary outcomes
Physical functioning
Time frame: 10 weeks and one year
Fear of falling
Time frame: 10 weeks and one year
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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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.
Harri Sievanen, ScD study director
The UKK Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Whole body vibration training and Wellness group in people with Falls and Physical Performance, run by UKK Institute at 4 sites in Finland.
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 14 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: stopped early, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls (time frame: One year). 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 11 May 2016.