CClinicalTrials.gg
CompletedNCT05213091Updated Sep 14, 2022

The Effect of Otago Exercises in the Elderly

An interventional study of Otago Exercise Programme in Healthy Aging, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Gazi University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2021, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

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). The control group is expected to continue their daily life. No attempt will be made by the researcher during the research process. Stratified randomization method according to age and gender was used in the study. The website was used to assign individuals meeting the inclusion criteria in each stratum to a determined number of groups. Masking will be done in terms of research data/output measurements (evaluator), statistician and reporting.

02

Conditions studied

  • Healthy Aging
03

In context

Lead sponsor

Gazi University is the lead sponsor of 532 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Otago Exercise Group

    Otago Exercise program wil be applied to the elderly.

    Other: Otago Exercise Programme

  • No intervention
    Control Group

    The elderly wil be expected to continue their daily life.

Interventions

  • OtherOtago Exercise Programme

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Totally 12 weeks

  2. 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 ".

    Time frame: Totally 12 weeks

  3. 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.

    Time frame: Totally 12 weeks

  4. 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.

    Time frame: Totally 12 weeks

  5. 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.

    Time frame: Totally 12 weeks

  6. 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.

    Time frame: Totally 12 weeks

  7. 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.

    Time frame: Totally 12 weeks

07

Study locations

1 site
  • Gazi University
    Ankara, Çankaya/Ankara 06490, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05213091
Lead sponsor
Gazi University
Responsible party
Naile Bilgili (Professor, Gazi University) — Principal investigator
First posted
Jan 28, 2022
Start date
Sep 20, 2021
Primary completion
Apr 15, 2022
Completion
Aug 15, 2022
Last update
Sep 14, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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