Frailty SyndromeNCT07458048
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
A study testing PILATES EXERCISES GROUP and CONVENTIONAL EXERCISES GROUP in people with Frailty Syndrome and Prefrail Elderly, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty Syndrome, Prefrail Elderly, Frail Elderly
- What is being tested?
- PILATES EXERCISES GROUP and CONVENTIONAL EXERCISES GROUP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Centro Reformer Pilates Center
Istanbul, Istanbul, 34710
Şükran Acar, +905346071963, acarsukran58@gmail.com
About this study
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.
Read more
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.
- Conditions
- Frailty Syndrome, Prefrail Elderly, Frail Elderly, Geriatric
- Being tested
- PILATES EXERCISES GROUP, CONVENTIONAL EXERCISES GROUP
- Keywords
- Pilates, geriatric, conventional, frailty, exercises, prefrail
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILATES EXERCISES GROUPOther
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 GROUPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Twenty older adults with prefrailty and frailty.The pilates program includes warm-up, strengthening, and cool-down exercises. Receives: Other: PILATES EXERCISES GROUP |
| Group B | Active comparator | Twenty older adults with prefrailty and frailty. The conventional program includes stretching, strengthening, and balance exercises. Receives: Other: CONVENTIONAL EXERCISES GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 6 weeks
Timed Up and Go Test (TUG)
Functional mobility and balance are evaluated based on movements required for daily living activities.
Measured: Baseline and 6 weeks
Secondary outcomes (8)
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Modified Borg Scale
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.
Measured: Baseline and 6 weeks
Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
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.
Measured: Baseline and 6 weeks
Mini-Mental State Examination (MMSE)
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.
Measured: Baseline and 6 weeks
Timed Up and Go Test (TUG)
Functional mobility and balance are evaluated based on movements required for daily living activities.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start22 Jun 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezen Karaborklu Argut, Istanbul University - Cerrahpasa
- Investigators
- Sezen Karabörklü ARGUT, Study director, Istanbul University - CerrahpasaŞükran Acar, Principal investigator, Istanbul University - CerrahpasaNeslihan Kabak, Principal investigator, Istanbul University - CerrahpasaEsma N Erden, Principal investigator, Istanbul University - CerrahpasaAyşe G Uçak Töre, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458048
- Sponsor's protocol ID
- 2026/139
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Qiu Y, Li G, Wang X, Liu W, Li X, Yang Y, Wang L, Chen L. Prevalence of multidimensional frailty among community-dwelling older adults: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Jun;154:104755. doi: 10.1016/j.ijnurstu.2024.104755. Epub 2024 Mar 14.
PubMed 38522186Zang W, Fang M, Meng L, Kong L, Xiao N, Xue J, Liu Z, Wu J, Zhang Y, Wei X, Zhang Z, Zhang Q. Exercise prescription prescriptions for frailty improvement in older adults: An evidence-based approach based on the 2024 older adult compendium. Arch Gerontol Geriatr. 2025 Mar;130:105717. doi: 10.1016/j.archger.2024.105717. Epub 2024 Dec 5.
PubMed 39671884
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
- ClinicalTrials.gov ID
- NCT07458048
- Acronym / sponsor ID
- 2026/139
- Conditions
- Frailty Syndrome, Prefrail Elderly, Frail Elderly, Geriatric
- Keywords
- Pilates, geriatric, conventional, frailty, exercises, prefrail
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: PILATES EXERCISES GROUPTwenty older adults with prefrailty and frailty.The pilates program includes warm-up, strengthening, and cool-down exercises. |
| Group B | Active comparator | Other: CONVENTIONAL EXERCISES GROUPTwenty older adults with prefrailty and frailty. The conventional program includes stretching, strengthening, and balance exercises. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PILATES EXERCISES GROUPThe 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. | Other | Group A |
| CONVENTIONAL EXERCISES GROUPThe 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. | Other | Group B |
Primary outcome
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).
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.
8 secondary outcomes
Functional Reach Test (FRT)
Time frame: Baseline and 6 weeks
30-Second Sit-to-Stand Test (30s STS)
Time frame: Baseline and 6 weeks
10-Meter Walk Test (10MWT)
Time frame: Baseline and 6 weeks
Geriatric Depression Scale (Yesavage GDS)
Time frame: Baseline and 6 weeks
Modified Borg Scale
Time frame: Baseline and 6 weeks
Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Time frame: Baseline and 6 weeks
Mini-Mental State Examination (MMSE)
Time frame: Baseline and 6 weeks
Timed Up and Go Test (TUG)
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 38522186Qiu Y, Li G, Wang X, Liu W, Li X, Yang Y, Wang L, Chen L. Prevalence of multidimensional frailty among community-dwelling older adults: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Jun;154:104755. doi: 10.1016/j.ijnurstu.2024.104755. Epub 2024 Mar 14.
- Background: PubMed 39671884Zang W, Fang M, Meng L, Kong L, Xiao N, Xue J, Liu Z, Wu J, Zhang Y, Wei X, Zhang Z, Zhang Q. Exercise prescription prescriptions for frailty improvement in older adults: An evidence-based approach based on the 2024 older adult compendium. Arch Gerontol Geriatr. 2025 Mar;130:105717. doi: 10.1016/j.archger.2024.105717. Epub 2024 Dec 5.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sezen Karabörklü ARGUT study director
Istanbul University - Cerrahpasa
Şükran Acar principal investigator
Istanbul University - Cerrahpasa
Neslihan Kabak principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILATES EXERCISES GROUP and CONVENTIONAL EXERCISES GROUP in people with Frailty Syndrome and Prefrail Elderly, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sezen Karabörklü Argut, assistant professor (+905301712421, s.karaborkluargut@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FRAIL Scale (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07458048, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.