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

NCT07522125 | Completed

• 1 other identifier: SelcukU-GUzun-003
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Older Adults

Keywords

older adults; frailty; Cognitive Function; Sleep Quality; Multicomponent Exercise Program; nursing

Outcome Measures

Primary Outcomes (3)

• Frailty total mean score

  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

  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

  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.

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group was a group of 55 people consisting of older adults who followed the 12-week Multicomponent Exercise Program.

Behavioral: The Multicomponent Exercise Program

Control Group

NO INTERVENTION

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.

Interventions

The Multicomponent Exercise Program BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• the presence of severe cardiovascular disease,
• diagnosed cognitive impairment (MMSE \<24),
• any condition that could prevent participation in physical exercise.

Sponsors & Collaborators

• Neslihan Lok: lead
• Selcuk University: collaborator

Study Sites (1)

Ankara Metropolitan Municipality Healthy Life Center

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the exercise intervention, participants and intervention providers could not be blinded to group allocation. However, outcome assessors and data analysts were blinded to group assignments to minimize assessment and analysis bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr

Model Details: This study was a randomized controlled trial with pre-test and post-test control groups.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: November 3, 2025
• Primary Completion: January 26, 2026
• Study Completion: February 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)