NCT05914012

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 13, 2023

Last Update Submit

June 13, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Edmonton Frail Scale

    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

    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)

    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

    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

    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

    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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Telerehabilitation based on Otago Exercise Program

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsA web-based randomization program (https://www.randomizer.org/) will be used to randomize participants 1:1 to the intervention and control groups, stratified by gender.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.
  • Not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments.

You may not qualify if:

  • 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.
  • Those who do not meet the specified age criteria for the study, fail to complete the assessments, and continue the rehabilitation program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kınıklı, 20070, Turkey (Türkiye)

Location

Related Publications (3)

  • 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. 2025 Dec;34(12):5130-5143. doi: 10.1111/jocn.15964. Epub 2021 Jul 21.

  • 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).

    RESULT
  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT. PhD. Assist. Prof.

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 22, 2023

Study Start

December 22, 2021

Primary Completion

July 1, 2022

Study Completion

May 31, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations