Skip to content

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07522125
Enrollment
110
Registered
2026-04-13
Start date
2025-11-03
Completion date
2026-02-10
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older Adults

Keywords

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

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. 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.

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.

Interventions

BEHAVIORALThe 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.

Sponsors

Neslihan Lok
Lead SponsorOTHER
Selcuk University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frailty total mean scoreFrom enrollment to the end of the multicomponent exercise program at 12 weeksFrailty 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.
Cognitive function total mean scoreFrom enrollment to the end of the multicomponent exercise program at 12 weeksCognitive 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
Sleep quality total mean scoreFrom 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026