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Functional Status in COPD Patients After Exercise Rehabilitation Program

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06142266
Collaborator
(none)
120
Enrollment
2
Arms
18
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the effectiveness of the exercise program in improving physical fitness and exercise capacity in COPD patients like walking distance, muscle strength, endurance will be measured before and after the program.

To assess whether the program helps reduce COPD symptoms like shortness of breath and fatigue during daily activities. Quality of life questionnaires will be used.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise rehabilitation program
 N/A

Detailed Description

Pulmonary rehabilitation is a comprehensive, multidisciplinary program that utilizes exercise training and patient education to improve the physical and psychological condition of people living with chronic respiratory diseases Exercise therapy and education work in an integrated manner to help patients better manage their condition.

Exercise therapy is a core component of pulmonary rehabilitation. Regular physical activity helps build endurance, strengthen respiratory muscles, and improve overall functional capacity . Both aerobic and resistance exercises are prescribed according to individual abilities and needs .Studies have shown exercise training can reduce symptoms, increase quality of life, and decrease healthcare utilization among pulmonary patients .Patient education teaches self-management skills like breathing techniques, medication management, coping strategies, and how to prevent or deal with exacerbations . Educating patients empowers them to better understand their condition and play an active role in their care. It also helps address anxiety and depression that often accompany chronic lung disease .

Recent reviews continue to support the benefits of pulmonary rehabilitation's holistic, exercise-education approach meta-analysis found multidisciplinary programs significantly improved outcomes such as hospital admissions compared to usual care . Additionally, study showed telerehabilitation with remote exercise monitoring and video classes achieved comparable benefits to traditional center-based programs . In summary, exercise therapy and education are core components of effective pulmonary rehabilitation

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trial conducted at Chest Department at Assiut University Hospitalrandomized controlled trial conducted at Chest Department at Assiut University Hospital
Masking:
Single (Participant)
Masking Description:
Participants will be randomly allocated to either the intervention or control group in a 1:1 ratio using computer-generated randomization
Primary Purpose:
Supportive Care
Official Title:
Assessment of Improvement in Functional Status in Moderate to Severe Stable COPD Patients After Exercise Rehabilitation Program
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

The intervention group (n=60) will undergo a 12-week pulmonary rehabilitation program. This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs.

Other: Exercise rehabilitation program
This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs for 12-week
Active Comparator: Control group

The control group (n=60) will receive usual medical care according to guidelines, which may include bronchodilator/anti-inflammatory therapy but no formal pulmonary rehabilitation.

Other: Exercise rehabilitation program
This program will consist of twice-weekly supervised exercise sessions, including aerobic training and resistance exercises targeting the lower limbs for 12-week

Outcome Measures

Primary Outcome Measures

  1. Improvement in exercise capacity [baseline]

    Asess by Change in 6-minute walk distant

Secondary Outcome Measures

  1. Health related quilt of life [baseline]

    Asess by St .George Questioner

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosis of moderate-severe chronic obstructive pulmonary disease (COPD) based on spirometry results and clinical assessment.

  • Age between 40 and 75 years. Stable disease status, defined as no exacerbations requiring admission to respiratory intensive care unit

  • Willingness and ability to participate in a 12-week pulmonary rehabilitation program.

Exclusion Criteria:

  • Presence of significant comorbidities or medical conditions that may interfere with participation in the pulmonary rehabilitation program (e.g., severe cardiovascular disease, musculoskeletal disorders, uncontrolled hypertension).

  • Inability to perform the required exercise activities due to physical limitations or disabilities.

Cognitive impairment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Heba fahmy, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hend Mohamed Sayed Mohamed, Lecture of chest diseases, Assiut University
ClinicalTrials.gov Identifier:
NCT06142266
Other Study ID Numbers:
  • COPD&Exercise rehabilitation
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 21, 2023