- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963387
Effects of Whole Body Vibrations on Functional Independence on Older Adults
July 5, 2021 updated by: Esha Khan, University of Lahore
Functional limitation and balance deficits occur with aging in normal healthy individuals due to decline in muscle strength.
Muscle strengthening exercises and balance training has shown improvement of functional status of elderly.
And whole body vibrations along with strengthen and balance training has been suggested to reduce the effects of aging in balance and functional abilities.
Aim of this study was to find out the additional effects of whole body vibration along with balance training in older adults.
It was a Randomized Control Trial Study.
Study setting was railway general hospital Rawalpindi.
Inclusion Criteria was Age 50 to 70 years old people, with moderate fall risk (BBS Score 21-40), both genders with Controlled diabetes and HTN, 112 Subjects were randomly and equally allocated to experimental group(n=56) and control group(n=56) through toss and coin method.
Participants in both groups were examined for balance abilities with the Berg Balance Scale, Functional Independence Scale, & Timed up and Go Test (TUG) before and after 4 weeks treatment protocol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was a Randomized control trial.
Conducted in Railway General Hospital Rawalpindi from January 2019 to July 2019.
300 older adults were screened and 112 were selected on the basis of inclusion criteria.
Subjects were randomly allocated to control and experimental group through toss and coin method, 56 being in each group.
Control group subjects received balance and strengthening exercises 3 times in a week for 4 weeks.
While experimental group participants received same balance and strengthening exercises with whole body vibration 3 times in a week for 4 weeks.
Vibration exposure was given in 1-minute bouts, with rest period of one to two minutes between bouts, with the exposure whole body vibration for about four minutes on every session, Balance exercises included tandem walk 20 steps and single leg raise with weights 10 repetition.(8,9)
Tools used in this study were Berg Balance scale a 14 item scale.
The score of each item ranges from zero to four, zero being the last point and 4 being the highest point the total score for these 14 items were 56.
If the score is between 41 to56 then it is considered normal if it is from 20 to 40 the risk of balance deficits are moderate but if the score comes below 19 then risk of fall enhances.
Almost 10 to 15 minutes are required to perform this scale on an individual.
Functional Independence Measure It consisted of eighteen item; for motor items score 13 and five for cogitation which includes communication and cognition, each of the value is scored on a 7-point scale.
The third tool used in this study was Time Up and Go test asses the static and dynamic balance it requires the time taken by individual to raise from a chair walk three meters, turn around walk back and sit on the chair.
Subjects in both groups were pre assessed using these three tools and after completion of four weeks subjects were reassessed and the difference of score was noted.
Data of this study was analyzed by using SPSS software version 25.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Rehabilitation Department of Pakistan Railway Hospital Rawalpindi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 50 to 70 years
- With moderate fall risk (BBS Score 21-40)
- Both genders
- Controlled diabetes and hyper tension
Exclusion Criteria:
- Patient with any type of surgical intervention which may hinder assessment or treatment
- Patient with any cognitive dysfunction.
- Patients with neurological disease (i.e. stroke, vestibular cochlear issue)
- Patients with any behavioral problem
- Patient with ischemic heart disease, Tumors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole body vibration
Balance and muscle strengthening exercises with whole-body vibration, strengthening exercise included straight leg raise with weights, and balance training including walking heel to toe for 20 steps vibration exposure was given in 1-minute bouts, with rest period of one to two minutes between bouts, with the exposure whole body vibration for about four minutes on every session.
The duration of vibration exposure was preset with the automatic set time intervals in the vibration machine Prior to each vibration bout.
When the predefined time was reached the machine automatically turned off .
Based on previous researches the total exposure of four minutes per session interval was selected.
In this study frequency of 30Hz (4 weeks), with 0.9 mm vertical displacement was used.
|
Balance and muscle strengthening exercises with whole-body vibration, strengthening exercise included straight leg raise with weights, and balance training including walking heel to toe for 20 steps.
In this study frequency of 30Hz (4 weeks), with 0.9 mm vertical displacement was used.
|
|
Active Comparator: Balance and Strengthening exercise
Balance and strengthening exercises includes straight leg raise with weights 10 reps.
and tandem walk 20 steps 3 days in week for 4 weeks
|
Balance and strengthening exercises includes straight leg raise with weights 10 reps.
and tandem walk 20 steps 3 days in week for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Berg Balance Scale score
Time Frame: Baseline and 4 week
|
14 item scale was established for elder population to asses balance deficits in them.
The score of each item ranges from zero to four, zero being the last point and 4 being the highest point the total score for these 14 items were 56.
|
Baseline and 4 week
|
|
Change from Baseline in Functional Independence Scale score
Time Frame: Baseline and 4 week
|
It consist of eighteen item; for motor items score 13 and five for cogitation which includes communication and cognition, each of the value is scored on a 7-point scale
|
Baseline and 4 week
|
|
Change from Baseline in Timed Up and Go test
Time Frame: Baseline and 4 week
|
Define fall threat and assess the improvement of balance, sit to stand and walking.
|
Baseline and 4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Esha Khan, University of Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2019
Primary Completion (Actual)
September 29, 2019
Study Completion (Actual)
September 29, 2019
Study Registration Dates
First Submitted
July 5, 2021
First Submitted That Met QC Criteria
July 5, 2021
First Posted (Actual)
July 15, 2021
Study Record Updates
Last Update Posted (Actual)
July 15, 2021
Last Update Submitted That Met QC Criteria
July 5, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- RIPHAH/RCRS/REC/00517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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