Older Adults With Moderate Balance RiskNCT04963387
Effects of Whole Body Vibrations on Functional Independence on Older Adults
A study testing Whole body vibration and Balance and Strengthening exercise in people with Older Adults With Moderate Balance Risk, run by University of Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Older Adults With Moderate Balance Risk
- What is being tested?
- Whole body vibration and Balance and Strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2019to 29 Sep 2019
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 70 years
- With moderate fall risk (BBS Score 21-40)
- Both genders
- Controlled diabetes and hyper tension
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rehabilitation Department of Pakistan Railway Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000
About this study
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.
Read the 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.
- Conditions
- Older Adults With Moderate Balance Risk
- Being tested
- Whole body vibration, Balance and Strengthening exercise
- Keywords
- Balance, Whole Body Vibration, Berg Balance Scale, Older Adults, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationOther
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.
Balance and Strengthening exerciseOther
Balance and strengthening exercises includes straight leg raise with weights 10 reps. and tandem walk 20 steps 3 days in week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration | Experimental | 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. Receives: Other: Whole body vibration |
| Balance and Strengthening exercise | Active comparator | Balance and strengthening exercises includes straight leg raise with weights 10 reps. and tandem walk 20 steps 3 days in week for 4 weeks Receives: Other: Balance and Strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Berg Balance Scale score
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.
Measured: Baseline and 4 week
Change from Baseline in Functional Independence Scale score
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
Measured: Baseline and 4 week
Change from Baseline in Timed Up and Go test
Define fall threat and assess the improvement of balance, sit to stand and walking.
Measured: Baseline and 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start20 Mar 2019
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults With Moderate Balance RiskStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Model description
- Single center, parallel group randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Riphah International University
- Responsible party
- Principal investigator, Esha Khan, University of Lahore
- Investigators
- Esha Khan, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963387
- Sponsor's protocol ID
- RIPHAH/RCRS/REC/00517
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibrations on Functional Independence on Older Adults
- ClinicalTrials.gov ID
- NCT04963387
- Acronym / sponsor ID
- RIPHAH/RCRS/REC/00517
- Conditions
- Older Adults With Moderate Balance Risk
- Keywords
- Balance, Whole Body Vibration, Berg Balance Scale, Older Adults, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Riphah International University
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 15 Jul 2021 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration | Experimental | Other: Whole body vibrationBalance 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 Strengthening exercise | Active comparator | Other: Balance and Strengthening exerciseBalance and strengthening exercises includes straight leg raise with weights 10 reps. and tandem walk 20 steps 3 days in week for 4 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50 to 70 years
- With moderate fall risk (BBS Score 21-40)
- Both genders
- Controlled diabetes and hyper tension
Key exclusion criteria (5 listed)
- 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
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 vibrationBalance 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. | Other | Whole body vibration |
| Balance and Strengthening exerciseBalance and strengthening exercises includes straight leg raise with weights 10 reps. and tandem walk 20 steps 3 days in week for 4 weeks | Other | Balance and Strengthening exercise |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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.
Esha Khan principal investigator
University of Lahore
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 Balance and Strengthening exercise in people with Older Adults With Moderate Balance Risk, run by University of Lahore at 1 site in Pakistan.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jul 2021. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Berg Balance Scale score (time frame: Baseline and 4 week). The study lists 3 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 15 Jul 2021.