MedPath

A clinical trial to study the effect of exercises to improve quality of life in patients with COPD.

Phase 3
Conditions
Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Registration Number
CTRI/2023/05/053130
Lead Sponsor
Pt B D Sharma PGIMS Rohtak Haryana India
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. 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.

2. COPD stages from 2 to 4 (A-D) diagnosed according to GOLD criteria.

3. FEV1/FVC <0.7 and FEV1 <80% of predicted value.

4. Subjects undergoing stable respiratory medication with no exacerbations.

5. Patients willing to participate and given informed consent.

Exclusion Criteria

1. Subjects with acute exacerbation.

2. Have severe cognitive or psychotic impairment.

3. Musculoskeletal or neurological conditions that prevent exercise.

4. Unstable cardiovascular disease (e.g., unstable angina, aortic valve disease, unstable

pulmonary hypertension).

5. Patients requiring oxygen supplementation during exercise.

6. Patients with incapacity to follow a standard rehabilitation program.

7. Patients with shoulder pain, shoulder osteoarthritis, or shoulder surgery.

8. Rib fracture or a relevant infectious disease.

9. Pregnant or breastfeeding women.

10. H/O pneumonectomy or lobectomy in past 6month

11. Non-cooperative patients or patients under tutorship or curatorship.

12. Suffering from another disease like pulmonary hypertension or lung cancer.

13. Uncontrolled comorbidity on physician discretion.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Pulmonary functions- <br/ ><br>Forced Expiratory Volume in 1 second (FEV1) <br/ ><br>Forced Vital Capacity (FVC) <br/ ><br>FEV1/FVC <br/ ><br>2. Dyspnoea- Modified Borgâ??s scale (Hindi version)Timepoint: 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.
Secondary Outcome Measures
NameTimeMethod
1. Quality of life and dyspnoea associated with activities of daily living assessment <br/ ><br>-SGRQ Hindi version <br/ ><br>-COPD assessment test score CAT Hindi version <br/ ><br>2. Psychological status assessment â?? anxiety and <br/ ><br>depression scale DASS 21-Hindi <br/ ><br>3. Functional outcomes- <br/ ><br>â?¢ 6MWT <br/ ><br>â?¢ Arm activity levels <br/ ><br>4. Dyspnoea will be assessed after 6MWT Time to complete an activity (Glittre ADLâ??S test, PNF pattern D1-D2 with 0.5kg <br/ ><br>of weight, Grocery shelving task and Blackboard erasing taskTimepoint: 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.
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