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临床试验/CTRI/2023/05/053130
CTRI/2023/05/053130尚未招募3 期

Comparison of the effects of upper limb endurance and strength training on pulmonary functions, dyspnea, health related quality of life and functional outcomes in patients with COPD.

Pt B D Sharma PGIMS Rohtak Haryana India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. Pulmonary functions-

研究概览

简要总结

“The purpose of our study is to compare the effects of upper limbs endurance exercise training versus upper limbs strength exercise training in improving dyspnoea, FEV1, arm activity levels, exercise capacity, functional outcomes and HRQoL in patients with COPD during pulmonary rehabilitation program. In patients with COPD, Pulmonary rehabilitation plays a very important role. When a person with COPD performs exercises regularly there’s some improvement in the breathlessness and strength and endurance to perform their daily life activities, and their health related quality of life improved by improvement in the exercise capacity .Thus on account of this, we want to study and compare the effectiveness of upper limb endurance training and upper limb strength training and will help them to improve their quality of life and reduces their hospital stay and somehow will improve their anxiety and depression state of mind. Patients have to perform some exercises according to their health status for 4weeks, 3times a week for atleast 90min and have to fill different scales/parameters prior to training and after 4 weeks of training.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Men and women diagnosed with COPD according to GOLD criteria above the age of 40 years old will be recruited from OPD of Pt. B.D.S. PGIMS Rohtak.
  • COPD stages from 2 to 4 (A-D) diagnosed according to GOLD criteria.
  • FEV1/FVC <0.7 and FEV1 <80% of predicted value.
  • Subjects undergoing stable respiratory medication with no exacerbations.
  • Patients willing to participate and given informed consent.

排除标准

  • Subjects with acute exacerbation.
  • Have severe cognitive or psychotic impairment.
  • Musculoskeletal or neurological conditions that prevent exercise.
  • Unstable cardiovascular disease (e.g., unstable angina, aortic valve disease, unstable pulmonary hypertension).
  • Patients requiring oxygen supplementation during exercise.
  • Patients with incapacity to follow a standard rehabilitation program.
  • Patients with shoulder pain, shoulder osteoarthritis, or shoulder surgery.
  • Pregnant or breastfeeding women.
  • H/O pneumonectomy or lobectomy in past 6month
  • Non-cooperative patients or patients under tutorship or curatorship.
  • Suffering from another disease like pulmonary hypertension or lung cancer.
  • Uncontrolled comorbidity on physician discretion.

结局指标

主要结局

1. Pulmonary functions-

时间窗: Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up.

FEV1/FVC

时间窗: Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up.

Forced Expiratory Volume in 1 second (FEV1)

时间窗: Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up.

Forced Vital Capacity (FVC)

时间窗: Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up.

2. Dyspnoea- Modified Borg’s scale (Hindi version)

时间窗: Baseline readings will be taken prior to intervention at 1st week of intervention and then same parameters on end of 4th week and on 8th week of intervention on follow up.

次要结局

  • 1. Quality of life and dyspnoea associated with activities of daily living assessment(-SGRQ Hindi version)

研究者

发起方
Pt B D Sharma PGIMS Rohtak Haryana India
申办方类型
Government medical college

研究点 (1)

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