Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults

April 3, 2026 updated by: Neslihan Lok

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:

  1. Is a multicomponent exercise program effective in reducing frailty levels in older adults?
  2. Is a multicomponent exercise program effective in improving cognitive functions (memory, attention, and executive functions) in older adults?
  3. 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

Completed

Conditions

Detailed Description

The study was conducted with elderly individuals aged 65 and over enrolled in a municipal wellness centre meeting the inclusion-exclusion criteria. A total of 110 elderly individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control groups. Pre-test data were collected November 2025 in a quiet room at the wellness centre by outcome assessors from both the intervention and control groups using the "Personal Information Form", "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" on a self-report basis. The Multicomponent Exercise Program was administered to the intervention group for 12 weeks, twice a week, in groups of 6-8 people, in sessions lasting 45-60 minutes each, under nurse supervision. At the end of the Multicomponent Exercise Program, both the intervention and control groups were administered the "Edmonton Frail Scale (EFS)", "Mini Mental State Examination (MMSE)" and "Pittsburgh Sleep Quality Index (PSQI)" as a post-test between January and February 2026. The control group received no intervention during the 12-week program; individuals continued with their daily living activities.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey (Türkiye), 06000
        • Ankara Metropolitan Municipality Healthy Life Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Actual)

January 26, 2026

Study Completion (Actual)

February 10, 2026

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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