跳至主要内容
临床试验/CTRI/2022/04/041749
CTRI/2022/04/041749尚未招募不适用

Pulmonary and Extra-Pulmonary Profile of Chronic Obstructive Pulmonary Disease among Asian Indian population: Impact of Nutrition and Tele-Assisted Rehabilitation with Guided Exercise Training Study (In-Target study)

St Johns Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Quality of life measured using standard questionnaires, i.e.EuroQol5DL, St George Respiratory Questionnaire (SGRQ)

研究概览

简要总结

Pulmonary rehabilitation is an integral part of comprehensive COPD management. It has shown beneficial results in improving multiple COPD associated symptoms including a reduction in dyspnoea, exacerbation frequency, recurrent hospitalization and improvement in functional capacity, muscle strength and quality of life. The utilisation of pulmonary rehabilitation in the Indian setup is limited due to multiple constraints including space, expenditure, manpower and resources. Considering these challenges, this study has developed a structured rehabilitation program consisting of exercises, nutritional and motivational support that can be delivered in the patient’s home environment. A video-based exercise module will be created for the patients aided with weekly telehealth follow-up calls from the study investigator. The participants will receive personalised nutritional counselling along with a nutritional supplement for regular consumption, designed to address frequently prevalent malnutrition observed in the patients. Weekly telephonic sessions will be made for reinforcement of the benefits of lifestyle changes, gather information on patient wellbeing, compliance and progress on the program. The aim of the study is to evaluate the short-term and long-term effectiveness of a structured telehealth intervention on the overall quality of life of patients seen in a hospital setting in Karnataka, India

研究设计

研究类型
Interventional

入排标准

年龄范围
45.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •COPD patients with FEV1/FVC <0.7 Age 45 years to 80 years both male and female, all BMI categories Smokers and non-smokers.

排除标准

  • •History of active cardiovascular disease with surgical intervention Malignancy, hepatic or renal insufficiency History of major surgery, anaemia or tuberculosis in previous 6 months History of injury in past 3 months that significantly affect physical functionality.

结局指标

主要结局

Quality of life measured using standard questionnaires, i.e.EuroQol5DL, St George Respiratory Questionnaire (SGRQ)

时间窗: Post intervention measure after completion of 8 weeks intervention. | Follow up at 16 weeks, 24 weeks and 1 year post intervention

次要结局

  • Pulmonary function: FEV1, FVC, ratio of FEV1/ FVC(Emphysema and muscle and adipose tissue mass and distribution on L1 and pectoralis (mm) measured by quantitative chest CT)

研究者

发起方
St Johns Research Institute
申办方类型
Research institution

研究点 (1)

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