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临床试验/NCT02218918
NCT02218918已完成不适用

Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients

PSG Hospitals2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年7月1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
发起方
入组人数
40
试验地点
2
主要终点
Quality of Life (Chronic Respiratory Questionnaire)

研究概览

简要总结

Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.

详细描述

Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is a promising management in COPD management. Exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. However access to traditional supervised exercise programs is questionable debate even in developed western countries. Unsupervised ground walk programs are often told by physicians but not properly prescribed.

Objective

To assess whether ground or treadmill walk is better in improving functional capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure: Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The intensity and progression of walk is based on 6 minute walk test. Quality of life will be gauged through Chronic respiratory questionnaire and functional capacity through 6 minute walk test.

Statistical analysis

Descriptive analysis for characterisation. Normality though Kolmogorov and Variables will be compared through paired and unpaired student t tests

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
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stable COPD
  • Stage II - IV
  • Both genders

排除标准

  • Cardiovascular diseases uncompensated
  • uncompensated pleural diseases
  • uncompensated liver diseases
  • Recent surgeries less than 3 weeks
  • malignancy receiving chemo and radiotherapy
  • Recent exacerbations less than 3 months

研究组 & 干预措施

Supervised Treadmill Walk Training

Active Comparator

Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks

干预措施: Supervised Treadmill Walk training (Behavioral)

Supervised Ground walk training

Experimental

Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks

干预措施: Ground walk training (Behavioral)

结局指标

主要结局

Quality of Life (Chronic Respiratory Questionnaire)

时间窗: Baseline, 6 weeks

CRQ - interviewer based

Functional Capacity (6 MINUTE WALK TEST)

时间窗: Baseline, 6 weeks

6 minute walk test according to standardisation of ATS

次要结局

未报告次要终点

研究者

发起方
PSG Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Baskaran Chandrasekaran

Senior Physiotherapist

PSG Hospitals

研究点 (2)

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