Effects of Whole Body Vibrations on Functional Independence on Older Adults

NCT ID: NCT04963387

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2019-09-29

Brief Summary

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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

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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

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Older Adults With Moderate Balance Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center, parallel group randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Whole body vibration

Intervention Type OTHER

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 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

Group Type ACTIVE_COMPARATOR

Balance and Strengthening exercise

Intervention Type OTHER

Balance and strengthening exercises includes straight leg raise with weights 10 reps. and tandem walk 20 steps 3 days in week for 4 weeks

Interventions

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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. In this study frequency of 30Hz (4 weeks), with 0.9 mm vertical displacement was used.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role collaborator

University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Esha Khan

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esha Khan

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

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Rehabilitation Department of Pakistan Railway Hospital Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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RIPHAH/RCRS/REC/00517

Identifier Type: -

Identifier Source: org_study_id

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