Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PILATES EXERCISES GROUP
Other interventionThe 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 interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
FRAIL Scale
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).
Time frame
Baseline and 6 weeks2
Timed Up and Go Test (TUG)
Functional mobility and balance are evaluated based on movements required for daily living activities.
Time frame
Baseline and 6 weeksSecondary outcomes
1
Functional Reach Test (FRT)
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.
Time frame
Baseline and 6 weeks2
30-Second Sit-to-Stand Test (30s STS)
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.
Time frame
Baseline and 6 weeks3
10-Meter Walk Test (10MWT)
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.
Time frame
Baseline and 6 weeks4
Geriatric Depression Scale (Yesavage GDS)
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.
Time frame
Baseline and 6 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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