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临床试验/NCT07442240
NCT07442240已完成不适用

Effects of Intradialytic Dynamic Lumbar Stabilization Exercises and Inspiratory Muscle Training on Functional Independence in Patients Undergoing Maintenance Hemodialysis

Bandırma Onyedi Eylül University0 个研究点目标入组 56 人开始时间: 2016年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
主要终点
Six-Minute Walk Test

研究概览

简要总结

This study evaluated whether a rehabilitation program performed during hemodialysis sessions could improve daily functioning and mobility in adults receiving maintenance hemodialysis. Participants took part in either exercise-based rehabilitation, breathing muscle training, or usual care. The study compared changes in functional independence and mobility before and after the rehabilitation period.

详细描述

This academic clinical study was conducted in two dialysis centers in Istanbul between June 2016 and March 2017. Adults undergoing maintenance hemodialysis were allocated to one of three groups: dynamic lumbar stabilization exercises, inspiratory muscle training, or a control group receiving routine nephrological care.

Participants in the intervention groups completed a supervised intradialytic rehabilitation program three times per week for 10 weeks. Functional independence and mobility-related performance were assessed at baseline and after completion of the intervention using validated functional assessment measures. The study was conducted as part of a doctoral thesis and is being retrospectively registered for transparency.

研究设计

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

盲法说明

Outcome assessments were performed by a physiotherapist who was blinded to group allocation.

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 25 to 45 years.
  • Diagnosis of chronic kidney disease undergoing maintenance hemodialysis.
  • Receiving hemodialysis for at least 6 months.
  • Hemodialysis schedule of three sessions per week, four hours per session.
  • Clinically stable at the time of enrollment.
  • Ability to participate in exercise and functional assessments.
  • Provided written informed consent.

排除标准

  • Acute medical conditions or unstable cardiovascular disease.
  • Severe musculoskeletal, neurological, or orthopedic disorders limiting exercise participation.
  • Severe cognitive impairment or inability to follow instructions.
  • Uncontrolled hypertension or other conditions contraindicating exercise.
  • Participation in another structured exercise or rehabilitation program during the study period.

研究组 & 干预措施

Dynamic Lumbar Stabilization Exercise (DLSE)

Experimental

Participants received a supervised intradialytic dynamic lumbar stabilization exercise program three times per week for 10 weeks in addition to usual care.

干预措施: Dynamic Lumbar Stabilization Exercises (Behavioral)

Respiratory Muscle Training (RMT)

Experimental

Participants received supervised respiratory muscle training during hemodialysis sessions three times per week for 10 weeks in addition to usual care.

干预措施: Respiratory Muscle Training (Behavioral)

Control Group

No Intervention

Participants received routine nephrological care during hemodialysis without additional exercise or rehabilitation interventions.

结局指标

主要结局

Six-Minute Walk Test

时间窗: Baseline and after 10 weeks

Functional exercise capacity assessed as the distance walked in six minutes, measured according to standardized procedures.

次要结局

  • Timed Up and Go Test (TUG)(Baseline and after 10 weeks)
  • Five Times Sit-to-Stand Test (5STS)(Baseline and after 10 weeks)
  • Maximal Inspiratory Pressure (MIP)(Baseline and after 10 weeks)
  • Maximal Expiratory Pressure (MEP)(Baseline and after 10 weeks)
  • Forced Vital Capacity (FVC)(Baseline and after 10 weeks)
  • Forced Expiratory Volume in 1 Second (FEV1)(Baseline and after 10 weeks)

研究者

发起方
Bandırma Onyedi Eylül University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serpil Çolak

Assistant Professor

Medipol University

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