- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914012
Telerehabilitation Based on Otago Exercises for Older Adults
June 13, 2023 updated by: Güzin Kara, Pamukkale University
The Effects of Telerehabilitation Program Based on Otago Exercises on Balance, Frailty and Quality of Life in tOlder Adults: A Randomized-Controlled Study
This study is a single-blind, randomized controlled, prospective clinical trial.
At least 62 older adults aged 65 and over were included in the study.
Evaluations were made twice, before starting the study and after completion.
Otago Exercise Program based on telerehabilitation was applied to the intervention group for a total of 21 sessions, 7 days a week for 3 weeks.
The control group did not participate in any exercise program during the study period; however, it was reported that they could be included in the Otago Exercise Program at the end of the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sociodemographic data and information about falling were recorded.
Edmonton Frail Scale, Modified Fall Efficiency Scale, Five-Dimensional European Quality of Life Scale-5D-3L, Timed Up and Go Test, Four-Step Balance Test and 30 sec Sit to StandTest were applied to all older adults.
Evaluations were applied at the beginning and end of the study.
A total of 21 sessions of Otago Exercise Program were applied to the intervention group, 30 minutes/session, 7 days/week for 3 weeks.
A printed physical activity recommendation brochure prepared for the older adults by the Ministry of Health of the Republic of Turkey was distributed to both groups.
The older adults in the control group did not participate in any exercise program during the study period.
Study Type
Interventional
Enrollment (Actual)
250
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
-
-
Kınıklı
-
Denizli, Kınıklı, Turkey, 20070
- Pamukkale University
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria for Intervention Group:
- Sedentary and sedentary older adults who do not have any neurological, cognitive, or communication problems that may affect assessments, and who volunteer to participate in the study.
Inclusion Criteria for Control Group:
- Not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments.
Exclusion Criteria for Intervention Group:
- Participants who have communication problems, are younger than 65 years old, have any neurological diagnosis and have orthopedic, mental and communication problems that prevent evaluations, and do not consent to participate in the study.
Exclusion Criteria for Control Group:
- Those who do not meet the specified age criteria for the study, fail to complete the assessments, and continue the rehabilitation program.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
125 older adults aged 65 and over, who do not have any neurological, cognitive and communication problems that may affect the evaluations, and who volunteer to participate in the study and who are sedentary.
|
It took a total of 21 sessions, 7 days a week for 3 weeks.
The sessions lasted 30 minutes.
It is recommended to do exercises with comfortable shoes at least 1 hour after a meal.
Each of his exercises will be videotaped and numbered and delivered to the intervention group via social networks and the Internet or by memory.
In each exercise session, the physiotherapist followed the exercise sessions through social networks and answered questions from the older adults.
|
|
No Intervention: Control Group
125 older adults not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Edmonton Frail Scale
Time Frame: 8 months
|
The scale consists of nine areas of vulnerability, which are considered to be the determinants of vulnerability.
Among these vulnerability areas, general health status and drug use are evaluated with two questions, and other areas with a single question.
The scale consists of 11 items in total.
Two areas of cognitive and functional performance are tested using performance-based items.
Clock testing is used for cognitive status and timed up-and-go testing is used for functional performance.
The test takes less than five minutes to administer.
The minimum total score is zero and the maximum score is 17.
An increase in the total score obtained from the scale indicates that the severity of vulnerability increases.
fragility to scale; It consists of five levels: not fragile, sensitive, slightly fragile, moderately fragile, and severely fragile.
The Turkish version of the scale was found to be valid and reliable.
|
8 months
|
|
The Modified Falls Efficacy Scale
Time Frame: 8 months
|
The Modified Fall Efficiency Scale is an expanded version of the Fall Efficiency Scale, which includes items questioning confidence during 4 different outdoor activities.
The scale evaluates the sense of security related to activities of daily living (such as dressing, bathing, crossing) on a ten-point visual analog scale.
10 items of the scale are related to indoor activities and 4 items are related to outdoor activities.
Items in the scale are scored between 0 (not confident) and 10 (completely sure) to assess the participants' self-efficacy regarding falling.
The scale score is calculated by dividing the sum of the scores per question by the number of questions.
A high score means a high sense of safety and competence against falling.
The Turkish validity and reliability study of the questionnaire was conducted.
|
8 months
|
|
The Five-Dimensional European Quality of Life Scale (EQ-5D-3L)
Time Frame: 8 months
|
Consisting of five dimensions: movement, self-care, usual activities, pain/discomfort, and anxiety/depression, this scale was developed by the European Quality of Life Research Society (EuroQol) in 1990 to measure health-related quality of life.
Each dimension of the scale is calculated over 3 points as no problem, some problem and major problem.
In addition, individuals indicate their current health status by marking on a visual analog scale (0-100 points).
The Turkish version was found to be valid and reliable.
|
8 months
|
|
The Timed Up and Go Test
Time Frame: 8 months
|
The Timed Get Up and Go Test was developed in 1991 by Podsiadlo and Richardson.
For the test, the individual is asked to get up from a standard chair, walk 3 meters, return and sit back in the chair.
The duration begins with the individual getting up from the chair and ends with sitting down.
The result is recorded in seconds.
|
8 months
|
|
The Four Step Balance Test
Time Frame: 8 months
|
The test consists of four different tasks (feet together, semi-tandem, tandem, and standing on one leg) that become increasingly difficult in the standing position.
After the patient regains his balance, the physiotherapist releases the support and the patient is asked to maintain the position.
During this time, the time is kept and recorded in seconds.
If the patient can hold the position for 10 seconds without moving his feet or needing support, the next position is passed.
|
8 months
|
|
The 30 sec Sit to Stand Test
Time Frame: 8 months
|
The patient sits in a chair with a standard sitting height and backrest.
They cross their hands on their chest.
The patient is asked to sit and stand up from the chair as quickly as possible.
The number of sitting and getting up is noted by keeping a 30-second timer with a stopwatch.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen X, Zhao L, Liu Y, Zhou Z, Zhang H, Wei D, Chen J, Li Y, Ou J, Huang J, Yang X, Ma C. Otago exercise programme for physical function and mental health among older adults with cognitive frailty during COVID-19: A randomised controlled trial. J Clin Nurs. 2021 Jul 21:10.1111/jocn.15964. doi: 10.1111/jocn.15964. Online ahead of print.
- Binns E, Taylor D. The effect of the Otago Exercise Programme on strength and balance in community dwelling older women. New Zealand Journal of Physiotherapy. 2011;39(2).
- Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015 Jun;21(4):202-13. doi: 10.1177/1357633X15572201. Epub 2015 Feb 22.
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)
December 22, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
June 13, 2023
First Submitted That Met QC Criteria
June 13, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- E-60116787-020-136972
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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