- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522125
Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults
Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults: A Randomized Controlled Trial
This study was aimed to examine the effects of participation in a 12-week multicomponent exercise program on frailty, cognitive function, and sleep quality among older adults.
The primary research questions of this study are as follows:
- Is a multicomponent exercise program effective in reducing frailty levels in older adults?
- Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults?
- Is a multicomponent exercise program effective in improving sleep quality in older adults? The study hypothesizes that participation in a multicomponent exercise program will lead to a reduction in frailty levels, improvement in cognitive functions, and enhancement of sleep quality among older adults.
Researchers were compared the multicomponent exercise program to a control group (no intervention) to see if the multicomponent exercise program works on frailty, cognitive function, and sleep quality among older adults.
Intervention group participants were:
- attended the multicomponent exercise program, 12-week period, with sessions held twice weekly, each lasting 45-60 minutes, in groups of 6-8 participants at a municipally affiliated healthy living center under nurse supervision.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06000
- Ankara Metropolitan Municipality Healthy Life Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 65 years or older, absence of severe physical disability,
- no medical contraindications to exercise,
- a Mini-Mental State Examination (MMSE) score ≥24 indicating no significant cognitive impairment,
- provision of written informed consent.
Exclusion Criteria:
- the presence of severe cardiovascular disease,
- diagnosed cognitive impairment (MMSE <24),
- any condition that could prevent participation in physical exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The intervention group was a group of 55 people consisting of older adults who followed the 12-week Multicomponent Exercise Program.
|
The program is conducted twice a week for 12 weeks, in sessions lasting 45-60 minutes each, at a municipal health center, in groups of 6-8 people, and under the supervision of a nurse.
Each exercise session consists of four phases: warm-up, aerobic exercise, strength and balance training, and cool-down.
The warm-up phase includes light-paced walking and range of motion exercises; the aerobic phase involves moderate-intensity walking and rhythmic movements; the strength and balance exercise phase uses resistance bands and light weights to target upper and lower extremity muscle groups; and exercises aimed at improving postural stability through functional activities such as sit-to-stand, single-leg standing, and tandem walking.
The cool-down phase includes static stretching exercises, breathing exercises, and relaxation techniques.
|
|
No Intervention: Control Group
The control group consisted of 55 older adults who attended receive any exercise intervention and were instructed to continue their routine daily activities for 12 weeks without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty total mean score
Time Frame: From enrollment to the end of the multicomponent exercise program at 12 weeks
|
Frailty was assessed using the Edmonton Frail Scale (EFS), a multidimensional instrument comprising nine domains that evaluate frailty in older adults.
Total scores range from 0 to 17, with higher scores indicating increased frailty.
|
From enrollment to the end of the multicomponent exercise program at 12 weeks
|
|
Cognitive function total mean score
Time Frame: From enrollment to the end of the multicomponent exercise program at 12 weeks
|
Cognitive function was measured using the Mini-Mental State Examination (MMSE), which evaluates orientation, registration, attention and calculation, recall, and language skills.
Scores range from 0 to 30, with higher scores reflecting better cognitive performance
|
From enrollment to the end of the multicomponent exercise program at 12 weeks
|
|
Sleep quality total mean score
Time Frame: From enrollment to the end of the multicomponent exercise program at 12 weeks.
|
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of seven components evaluating sleep quality over the past month.
Higher total scores indicate poorer sleep quality
|
From enrollment to the end of the multicomponent exercise program at 12 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukU-GUzun-003
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
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.