NCT05213091

Brief Summary

Home-based and individually designed exercise program; It consists of warming up, strengthening, balance exercises and walking plan. The number, intensity and duration of the movements are personalized according to preference and ability and are progressed gradually. Elderly individuals are expected to do this set of exercises three times a week and walk for 30 minutes twice a week. Since the Otago Exercise Programme includes combined exercises, the outputs of the effectiveness of the program will be different. For this purpose, the effect of otago exercises on fear of falling, balance, strengthening and functional mobility will be determined in the elderly living in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

December 24, 2021

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Modified Fall Efficacy Scale

    The scale is used to determine the possible fear of falling in elderly individuals. It is a visual analog scale consisting of fourteen questions. Items are scored from zero to ten (never safe=0, totally safe=10). A high score means high fall safety and proficiency.

    Totally 12 weeks

  • Berg Balance Scale

    The scale was developed to evaluate the balance levels of elderly individuals. This scale consists of 14 items and each section is scored between 0 (bad) and 4 (best). The scale score is in the range of 0-56 points, and an increase in the score indicates that the balance is good. According to the total score obtained, "0-20 points: high risk of falling, balance disorder", "21-40 points: moderate risk of falling, presence of acceptable balance", "41-56 points: low risk of falling, presence of good balance" evaluated as ".

    Totally 12 weeks

  • Elderly Empowerment Scale

    The scale is a short and practical tool for assessing the empowerment levels of the elderly. The scale, which consists of a total of eight questions and a single factor, is in the five-point Likert type. The lowest score obtained from the scale is 8, the highest score is 40.

    Totally 12 weeks

  • 30-Second Chair Stand Test

    It is a test that evaluates the sit-to-stand activity, lower extremity strength and dynamic balance of the individual. The number of times an individual sits and stands in 30 seconds is recorded. Three measurements will be made by giving rest intervals and the average will be recorded.

    Totally 12 weeks

  • Handgrip Strength Measurement Test

    The purpose of the test is to test the maximum isometric contraction strength of the forearm muscles. The average of the three measurements will be taken and recorded.

    Totally 12 weeks

  • Timed Up & Go

    It is a test that evaluates mobility and fall risk in elderly individuals. The individual is observed while getting up from the chair, walking 3 meters, turning, walking back and sitting again, and the elapsed time is recorded. If the elderly person completes this test in more than 12 seconds, it is considered as "at risk of falling". Three measurements will be made by giving rest intervals and the average will be taken.

    Totally 12 weeks

  • 6-Minute Walk Test

    It was developed to measure the functional capacity of individuals. In the six-minute walking test, the patient walks along a 30-meter straight corridor as fast as he can, but without running. How many meters he walked is measured and recorded. Three measurements will be made by giving rest intervals and the average will be recorded.

    Totally 12 weeks

Study Arms (2)

Otago Exercise Group

EXPERIMENTAL

Otago Exercise program wil be applied to the elderly.

Other: Otago Exercise Programme

Control Group

NO INTERVENTION

The elderly wil be expected to continue their daily life.

Interventions

The first four weeks will be Otago Exercise Programme training and practice. For the next weeks, there will be institution visits and telephone interviews. Individuals will be given an Otago Exercise Programme training booklet, exercise chart and exercise diary to better manage this process. The research will be conducted in small groups (average 6-8).

Also known as: Otago exercise programme training and implementation, phone call, institution visit
Otago Exercise Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • To be 65 years or older
  • To be literate
  • Having no problem in verbal communication
  • Not having a disability based on sight, hearing and lack of limbs
  • Obtaining at least 91 points or more according to the Barthel Activities of Daily Living Index (to be mildly dependent or completely independent)
  • Mini Mental Test to be 24 points and above
  • Having a doctor's report that it will not interfere with exercise

You may not qualify if:

  • Having a medical contraindication for exercise
  • Having acute or terminal illnesses and serious chronic illnesses that limit participation in exercise sessions
  • Having a lower extremity fracture in the past year
  • Having had an operation in the last month
  • Being diagnosed with any neuropsychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Çankaya/Ankara, 06490, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research data/output measurements, analysis and reporting
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2021

First Posted

January 28, 2022

Study Start

September 20, 2021

Primary Completion

April 15, 2022

Study Completion

August 15, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations