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Completed

NCT Number: NCT07522125

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

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.

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Key information

Conditions

Older Adults Dyssomnias Frailty Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Metropolitan Municipality Healthy Life Center

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Neslihan Lok

Other

Collaborators

  • Selcuk University

Registry information

Official study title

Effects of a Multicomponent Exercise Program on Frailty, Cognitive Function, and Sleep Quality in Older Adults: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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