COMPARISON OF THE EFFICACY OF CONVENTIONAL EXERCISE AND PILATES IN PRE-FRAIL AND FRAIL OLDER ADULTS

March 6, 2026 updated by: Sezen Karaborklu Argut, Istanbul University - Cerrahpasa

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 prevent independent mobility.

-

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
Active Comparator: Group A
Twenty older adults with prefrailty and frailty.The pilates program includes warm-up, strengthening, and cool-down exercises.
Other: PILATES EXERCISES GROUP
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). Sessions are conducted twice weekly for six weeks, approximately 60 minutes per session.
Active Comparator: Group B
Twenty older adults with prefrailty and frailty. The conventional program includes stretching, strengthening, and balance exercises.
Other: CONVENTIONAL EXERCISES GROUP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Study Director: Sezen Karabörklü ARGUT, Istanbul University - Cerrahpasa
  • Principal Investigator: Şükran Acar, Istanbul University - Cerrahpasa
  • Principal Investigator: Neslihan Kabak, Istanbul University - Cerrahpasa
  • Principal Investigator: Esma N Erden, Istanbul University - Cerrahpasa
  • Principal Investigator: Ayşe G Uçak Töre, Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 9, 2026

Study Completion (Estimated)

December 9, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İÜ Cerrahpasa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly. Only de-identified and aggregated data may be used for academic purposes in accordance with ethics committee approval and institutional regulations.

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.

Clinical Trials on Frail Elderly

Clinical Trials on PILATES EXERCISES GROUP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe