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

NCT07458048 | Not Yet Recruiting

• 1 other identifier: İÜ Cerrahpasa
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Pilates; geriatric; conventional; frailty; exercises; prefrail

Outcome Measures

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).

  Baseline and 6 weeks

Secondary Outcomes (8)

• Timed Up and Go Test (TUG)

  Baseline and 6 weeks

• Functional Reach Test (FRT)

  Baseline and 6 weeks

• 30-Second Sit-to-Stand Test (30s STS)

  Baseline and 6 weeks

• 10-Meter Walk Test (10MWT)

  Baseline and 6 weeks

• Geriatric Depression Scale (Yesavage GDS)

  Baseline and 6 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Twenty older adults with prefrailty and frailty.The pilates program includes warm-up, strengthening, and cool-down exercises.

Other: PILATES EXERCISES GROUP

Group B

ACTIVE COMPARATOR

Twenty older adults with prefrailty and frailty. The conventional program includes stretching, strengthening, and balance exercises.

Other: CONVENTIONAL EXERCISES GROUP

Interventions

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). Sessions are conducted twice weekly for six weeks, approximately 60 minutes per session.

Group A

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.

Group B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Sezen Karabörklü ARGUT

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sezen Karabörklü Argut, assistant professor

CONTACT

+905301712421; s.karaborkluargut@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share