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临床试验/NCT04674930
NCT04674930已完成不适用

Effects of Home-based Exercise Program on Physical Functioning of Hemodialysis Patients.

Riphah International University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change in Six minute Walk test

研究概览

简要总结

This study is designed to provide a simple, home-based, low-moderate intensity exercise program in chronic renal disease patients who are undergoing hemodialysis in order to improve physical performance, decrease the level of fatigue and eventually increase quality of life in patients. A randomized control trial will be conducted including patients on hemodialysis, who will be randomly allocated to interventional and control groups. Both the groups will receive six weeks of treatment, 3 times per week. Data will be collected at baseline, 3rd week and 6th week. Outcome measures include assessment of physical functioning including six-minute walk test, standing balance, 4-metre gait speed, chair stand, fatigue assessment scale and quality of life in kidney disease patients on hemodialysis.

详细描述

Chronic Kidney Disease (CKD) is defined as the structural and functional abnormalities of kidney along with decreased Glomerular Filtration Rate (GFR) < 60 ml/min/1.73 m2 for 3 months. It also refers to an irreversible deterioration in renal function that usually develops over a period of years it represents not only as a biochemical abnormality but, eventually, loss of the excretory, metabolic and hormonal functions of the kidney which leads to the clinical symptoms and signs of renal failure. The alarmingly high prevalence of reduced GFR in adult men and women in Pakistan is not unexpected as the prevalence of risk factors of CKD including hypertension and diabetes is one of the highest reported worldwide. The prevalence rate of CKD is found to be 70% in Pakistan. Clinical sign of raised urea and creatinine should be found during routine blood tests. An early symptom is nocturia, tiredness or breathlessness, renal anemia or fluid overload, pruritus, anorexia, weight loss, nausea, vomiting and hiccups. In very advanced (chronic stage) renal failure, respiration may be particularly deep (Kussmaul breathing), metabolic acidosis, and patients may develop muscular twitching, fits, drowsiness and coma. Chronic kidney disease can be managed by lifestyle modifications (dietary management, weight management, physical activity) are the initial components of treatment. Blockade of the renin angiotensin aldosterone system, blood pressure control, optimally managed comorbid diabetes and avoidance of nephrotoxic medications to prevent worsening renal function are also part of management. Hemodialysis is a medical procedure to remove the waste products in the form of fluid from the blood and to correct electrolyte imbalances. This is accomplished using a machine and a dialyzer, also referred to as an artificial kidney. As dialysis requires patients to be seated for extended periods of time, the risk of developing obesity, high blood pressure, decreased quality of life, musculoskeletal problems, such as low back pain and muscle tightness is higher than normal.

The physiotherapeutic exercise program during hemodialysis improves the quality of life (QOL) of chronic renal patients in physical, social, environmental and psychological. On regular basis physiotherapy intervention is to a lower frequency of edema and muscle cramps and to reduce the intensity of pain. It also influences the improvement of the respiratory function, showed by the evolution of the values maximal inspiratory pressure (IPmax), maximal expiratory pressure (EPmax) and peak expiratory flow.

Studies reported that aerobic as well as strength training proved to have favorable short and long-term effects on the physical performance and the functional balance in patients on maintenance renal hemodialysis.

All patients undertaking hemodialysis (HD) are recommended to exercise to some extent. Intra-dialytic resistance training program is also feasible and effective, causing improvement in physical functioning by improving the strength, exercise capacity and performance in physical tests. Patients with chronic renal failure on hemodialysis, inspiratory muscle training induces improvement in respiratory muscle strength, functional capacity, lung function and quality of life. Inspiratory muscle training can improve maximal respiratory pressures, lung function, functional capacity and quality of life in patients with chronic renal failure who are receiving hemodialysis.

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)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undertaking hemodialysis sessions for last 3 months
  • •Hemodynamically stable patients
  • •Stable clinical and functional state for at least 4 weeks
  • •Conscious level preserved
  • •Stage 5, Kidney Failure (GFR <15)

排除标准

  • •Patients with acute illness or infection, recent surgery, or vascular intervention
  • •Hospitalized within past 4 weeks (with dialysis or non-dialysis reasons)
  • •Uncontrolled Hypertension
  • •Patients with difficulty walking, without a walking aid owing to orthopedic problems
  • •Patients with neurological, musculoskeletal, cardiac and pulmonary disease and physical impairment

研究组 & 干预措施

Control group

No Intervention

Pharmacological management

Exercise group

Experimental

Aerobic training: The target training zone was set at 40-60% of the peak heart rate, as determined in the baseline 6min walk test (6MWT), with a rating of 11-13 on the Borg rating of perceived Exertion scale.

Resistance Training: This training was prescribed at 70% of one repetition maximum (RM). Patients were instructed to train a variety of upper and lower body muscle groups (e.g., latissimus, deltoid, biceps, quadriceps, and gastrocnemius muscles), using Thera-band

干预措施: Exercise program (Other)

结局指标

主要结局

Change in Six minute Walk test

时间窗: 3 and 6 weeks of intervention

This is a sub-maximal exercise test used to assess endurance and functional capacity. The distance covered in 6 minutes, is used as the outcome, by which we compare the changes in performance capacity. This test is performed in a gallery having a distance of 20m in length, in a straight line. In starting, the patient rests for 5 minutes in a sitting position, after 5 minutes the vitals will be assessed in resting phase. The patients are instructed about the test method, during one- minute intervals patients can ask about the time remaining during the test, prior to the end of the test. The distance walked in meters is then noted and functional capacity is estimated.

次要结局

  • Short Performance Physical Battery test (SPPB)(3 and 6 weeks)
  • Fatigue Assessment Scale (FAS)(3 and 6 weeks)
  • Kidney Disease Quality of Life - Short form (SF 36) (KDQOL-SF 36)(3 and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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