跳至主要内容
临床试验/CTRI/2025/10/095563
CTRI/2025/10/095563尚未招募不适用

Comparison of Two Forms of Intradialytic Exercises on Strength, Balance and Quality of life in Elderly Hemodialysis Patients with CKD:A Randomized Clinical Trial

Self sponsored Project1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
2.Berg Balance Scale

研究概览

简要总结

The study will include both male and female elderly individuals aged 65 years and above with a Mini Mental State Examination score of 24 or more and a Berg Balance Scale score between 21 and 56 indicating mild to moderate impairment. Participants will be patients with chronic kidney disease undergoing dialysis for at least three months with a minimum of twenty five sessions. The intervention will be delivered during the first one to two hours of ongoing dialysis and outcome measures will be assessed thirty minutes after dialysis. Group A will perform static cycling and stretching three times per week for eight weeks at an intensity of fifty five to sixty percent of maximum heart rate. The program will include five minutes of warm up ten minutes of cycling and ten minutes of stretching of the tendoachilis and hamstrings focusing on aerobic resistance and flexibility training. Group B will undergo podiatric exercises twice per week for eight weeks at the same intensity. This will consist of five minutes of warm up twenty minutes of ankle mobility and strengthening exercises and five minutes of cool down emphasizing resistance and flexibility. The podiatric exercise program will include ankle circles ankle dorsiflexion and plantar flexion toe spreading toe curling using a towel resistance band exercises for dorsiflexion plantar flexion inversion and eversion and plantar fascia stretches thereby targeting ankle mobility and strengthening during dialysis sessions.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • The study will include both male and female elderly individuals aged sixty five years and above with a score of greater than twenty four on the Mini Mental State Examination as described by Folstein in nineteen seventy five.
  • Patients scoring between twenty one and fifty six on the Berg Balance Scale indicating mild to moderate impairment will be included.
  • Participants will be patients with chronic kidney disease who have been receiving dialysis for at least three months with a minimum of twenty five sessions.
  • The intervention will be delivered during the first one to two hours of ongoing dialysis and outcome measures will be assessed thirty minutes after dialysis.

排除标准

  • Individuals who have undergone surgery or been hospitalized in the past three months will be excluded.
  • Participants with lower limb amputations, severe balance impairments, severe visual or hearing loss, or neurological conditions such as stroke, amyotrophic lateral sclerosis, or multiple sclerosis will not be included.
  • Patients with orthopedic conditions such as severe osteoarthritis or recent fractures, and those diagnosed with unstable angina, post coronary artery bypass grafting, pulmonary embolism, or myocardial infarction will also be excluded.
  • All of these conditions are considered absolute contraindications for exercise.

结局指标

主要结局

2.Berg Balance Scale

时间窗: 8 WEEKS

3. Kidney Disease and Quality of Life (KDQOL™-36) 20

时间窗: 8 WEEKS

1. 30-Second Chair Stand 18

时间窗: 8 WEEKS

次要结局

  • The secondary outcomes of the study will include changes in balance measured by the Berg Balance Scale, changes in lower limb muscle strength assessed by manual muscle testing, changes in ankle mobility assessed using goniometry, changes in quality of life assessed using the Kidney Disease Quality of Life Short Form questionnaire, and changes in fatigue levels assessed by the Fatigue Severity Scale. All these outcomes will be measured at baseline and again after eight weeks of intervention.(0th week,4th week,8th week)

研究者

发起方
Self sponsored Project
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

RakshaPB

KAHER Institute of Physiotherapy

研究点 (1)

Loading locations...

相似试验