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临床试验/NCT07458048
NCT07458048尚未招募不适用

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

Istanbul University - Cerrahpasa0 个研究点目标入组 40 人开始时间: 2026年6月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
FRAIL Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Group B

Active Comparator

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

干预措施: CONVENTIONAL EXERCISES GROUP (Other)

Group A

Active Comparator

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

干预措施: PILATES EXERCISES GROUP (Other)

结局指标

主要结局

FRAIL Scale

时间窗: 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).

次要结局

  • 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)
  • Modified Borg Scale(Baseline and 6 weeks)
  • Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)(Baseline and 6 weeks)
  • Mini-Mental State Examination (MMSE)(Baseline and 6 weeks)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sezen Karaborklu Argut

Assistant Professor

Istanbul University - Cerrahpasa

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