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NCT Number: NCT07458048

Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults

Brief Summary

This clinical study aims to compare the effects of a conventional exercise program and a Pilates exercise program in prefrail and frail older adults. A total of 40 participants aged 60 years and older who are classified as prefrail or frail according to the FRAIL Scale will be included in the study.

Participants will be randomly assigned to either the conventional exercise group or the Pilates group. Both exercise programs will be conducted twice weekly for 6 weeks. The interventions will focus on stretching exercises, balance and perturbation training, and strength exercises targeting major muscle groups.

Primary outcomes will include changes in frailty status assessed before and after the intervention. Secondary outcomes will include functional mobility and balance assessed by the Timed Up and Go Test, dynamic balance assessed by the Functional Reach Test, lower extremity strength assessed by the 30-Second Sit-to-Stand Test, gait speed assessed by the 10-Meter Walk Test, depressive symptoms and psychological well-being assessed by the Yesavage Geriatric Depression Scale, independence in daily activities assessed by the Lawton Instrumental Activities of Daily Living Scale, cognitive status assessed by the Mini-Mental State Examination, and fatigue assessed by the Modified Borg Scale. Frailty status will be evaluated using the FRAIL Scale.

Throughout the study, participant safety will be monitored, and any adverse events, such as injuries or discomfort occurring during exercise sessions, will be recorded and managed appropriately.

This study is expected to provide valuable clinical evidence regarding the effectiveness of conventional exercise and Pilates programs in improving physical health and reducing frailty in prefrail and frail older adults, thereby contributing to the identification of best practice approaches for the management of this vulnerable population.

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Key information

Conditions

Frailty Syndrome Behavior Frail Elderly Frailty Geriatric Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Prefrail Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 60 years and older Classified as prefrail or frail according to the FRAIL Scale A score of 24 or higher on the Mini-Mental State Examination (MMSE) Provided written informed consent after being informed about the study

Exclusion criteria

Presence of unstable cardiovascular disease Having received physical therapy and rehabilitation within the past 6 months History of severe neurological disorders History of major surgery affecting mobility within the past 6-12 months Severe musculoskeletal or orthopedic conditions that limit or preventt independent mobility.

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Treatment and study plan

PILATES EXERCISES GROUP

Other

The Pilates-based exercise program is structured and supervised by a physiotherapist. The program includes controlled movements, postural alignment, core stabilization, breathing control, and progressive overload principles. Exercise intensity is individualized based on perceived exertion, targeting moderate intensity (Borg CR10 scale: 4-6). The program will be structured as 20 minutes of rest and 40 minutes of exercise applications to maintain participant tolerance.

Pilates is a safe and adaptable therapeutic modality for the elderly. Adjustable components like the foot bar and headrest allow for ergonomic modifications tailored to physical capacity and joint morphology. This customization facilitates controlled execution for individuals with mobility impairments. Diverse movement variations and graded progression enable program diversification. Furthermore, controlled breathing enhances trunk stability and rhythmic execution.

CONVENTIONAL EXERCISES GROUP

Other

The conventional exercise program is supervised by a physiotherapist and consists of range of motion exercises, stretching, strengthening exercises targeting major muscle groups, and balance training. Exercise intensity is individualized and maintained at moderate intensity. Sessions are conducted twice weekly for six weeks, approximately 60 minutes per session.

Primary outcomes

  1. FRAIL Scale

    Time frame: Baseline and 6 weeks

    The FRAIL Scale is a screening tool consisting of five items, each answered with a "Yes" or "No." Each "Yes" response is scored as 1 point and each "No" response as 0 points, resulting in a total score ranging from 0 to 5. Participants are classified as robust (0 points), prefrail (1-2 points), or frail (≥3 points).

  2. Timed Up and Go Test (TUG)

    Time frame: Baseline and 6 weeks

    Functional mobility and balance are evaluated based on movements required for daily living activities.

Secondary outcomes

  1. Functional Reach Test (FRT)

    Time frame: Baseline and 6 weeks

    The Functional Reach Test (FRT) is used to assess dynamic balance and the risk of falling. Participants are instructed to stand upright and reach forward as far as possible without taking a step or losing balance. The maximum distance reached is measured in centimeters. Greater reach distance indicates better dynamic balance performance.

  2. 30-Second Sit-to-Stand Test (30s STS)

    Time frame: Baseline and 6 weeks

    The 30-Second Sit-to-Stand Test is used to assess lower extremity muscle strength and functional performance. Participants are instructed to stand up and sit down from a standard chair as many times as possible within 30 seconds. The total number of completed stands is recorded. Higher scores indicate better lower limb strength and functional capacity.

  3. 10-Meter Walk Test (10MWT)

    Time frame: Baseline and 6 weeks

    The 10-Meter Walk Test (10MWT) is used to assess gait speed. Participants are instructed to walk at their usual walking speed along a 10-meter walkway. The time required to walk the middle 10 meters is recorded, and gait speed is calculated in meters per second (m/s). Higher gait speed values indicate better functional mobility and walking performance.

  4. Geriatric Depression Scale (Yesavage GDS)

    Time frame: Baseline and 6 weeks

    The Geriatric Depression Scale (GDS), developed by Yesavage et al., is used to assess depressive symptoms in older adults. The scale consists of yes/no questions designed to evaluate mood and psychological well-being. Total scores indicate the severity of depressive symptoms, with higher scores reflecting greater levels of depression.

  5. Modified Borg Scale

    Time frame: Baseline and 6 weeks

    The Modified Borg Scale is used to assess perceived exertion and fatigue. Participants are asked to rate their level of fatigue or exertion on a numerical scale ranging from 0 (no fatigue) to 10 (maximal fatigue). Higher scores indicate greater perceived fatigue.

  6. Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)

    Time frame: Baseline and 6 weeks

    The Lawton Instrumental Activities of Daily Living (IADL) Scale is used to assess independence in complex daily activities necessary for independent living. The scale evaluates functional abilities such as using the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Higher scores indicate greater independence in instrumental activities of daily living.

  7. Mini-Mental State Examination (MMSE)

    Time frame: Baseline and 6 weeks

    The Mini-Mental State Examination (MMSE) is used to assess global cognitive function. The test evaluates cognitive domains including orientation, registration, attention and calculation, recall, language, and visuospatial abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive function.

  8. Timed Up and Go Test (TUG)

    Time frame: Baseline and 6 weeks

    Functional mobility and balance are evaluated based on movements required for daily living activities.

Study contacts

Contact information is provided by the study sponsor or research team.

Sezen Karabörklü Argut, assistant professor

CONTACT

[email protected]

+905301712421

Şükran Acar, Master's degree

CONTACT

[email protected]

+905346071963

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Jun 25, 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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