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

Overview

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.

Interventions

• 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). 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 adapt
• 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.

Primary outcome measures

• FRAIL Scale [Time frame: Baseline and 6 weeks]
• Timed Up and Go Test (TUG) [Time frame: Baseline and 6 weeks]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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.

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38522186
• Zang 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. PMID 39671884

Identifiers

NCT: NCT07458048 · 2026/139

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗