- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07831174
Modified Otago Exercise Program on Neurocognitive Level and Balance Parameters
The Effect of Modified Otago Exercise Program on Neurocognitive Level and Balance Parameters in Community-Dwelling Older Adults: A Randomized Controlled Trial
This study examined the effect of an eight-week modified Otago Exercise Program on neurocognitive level and balance parameters in community-dwelling older adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eighty-seven individuals aged 65 years and over were assigned to an intervention group (n=43) or a control group (n=44) through block randomization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey (Türkiye)
- Alanya Alaaddin Keykubat University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be 65 years of age or older,
- Be able to walk at least ten meters unaided or with the support of a walking aid, - Not have a diagnosed neurological or orthopedic problem affecting walking and balance,
- Not have visual or hearing impairments, and score 24 or higher on the Standardized Mini Mental State Test.
Exclusion Criteria:
- Having undergone lower extremity surgery within the last six months and being illiterate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Otago Exercise
Otago exercise program + Daily routine |
Otago exercise + Daily routine |
|
Active Comparator: Control
Daily routine |
Only daily routine |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive State Test
Time Frame: Enrollment and the end of 8 week-intervention
|
Cognitive State Test is a tool for the detailed screening of cognitive function. It is scored out of a total of thirty points. A high score corresponds to high cognitive performance. |
Enrollment and the end of 8 week-intervention
|
|
Dynamic Balance Test
Time Frame: Enrollment and the end of 8 week-intervention
|
The Timed Up and Go Test was administered to assess dynamic balance. The time taken to complete the test was recorded; a shorter duration indicates good dynamic balance performance, whereas values exceeding 14 seconds are associated with an increased risk of falling. |
Enrollment and the end of 8 week-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Warwick-Edinburgh Mental Well-being Scale
Time Frame: Enrollment and at the end of the 8th week
|
It consists of fourteen five-point Likert-type items and yields scores ranging from fourteen to seventy. A high score indicates a high level of mental well-being. |
Enrollment and at the end of the 8th week
|
|
Single-Leg Stance Test
Time Frame: Enrollment and at the end of the 8th week
|
One leg is lifted without touching the supporting leg, and the individual is expected to maintain their balance for thirty seconds; the duration is recorded in seconds. |
Enrollment and at the end of the 8th week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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