Clinical trial NCT04963387: Effects of Whole Body Vibrations on Functional Independence on Older Adults
Official title: Effects of Whole Body Vibrations on Functional Independence on Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults With Moderate Balance Risk
Keywords: Balance
Whole Body Vibration
Berg Balance Scale
Older Adults
Physiotherapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
Collaborators: name: Riphah International University
First posted: 2021-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, parallel group randomized controlled trial
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Berg Balance Scale score
timeFrame: Baseline and 4 week
measure: Change from Baseline in Functional Independence Scale score
timeFrame: Baseline and 4 week
measure: Change from Baseline in Timed Up and Go test
timeFrame: Baseline and 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rehabilitation Department of Pakistan Railway Hospital Rawalpindi
state: Punjab
Study officials:
affiliation: University of Lahore
name: Esha Khan
role: PRINCIPAL_INVESTIGATOR
References: