NCT06142266

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

November 16, 2023

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in exercise capacity

    Asess by Change in 6-minute walk distant

    baseline

Secondary Outcomes (1)

  • Health related quilt of life

    baseline

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Interventions

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

Control groupIntervention group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gloeckl R, Schneeberger T, Jarosch I, Kenn K. Pulmonary Rehabilitation and Exercise Training in Chronic Obstructive Pulmonary Disease. Dtsch Arztebl Int. 2018 Feb 23;115(8):117-123. doi: 10.3238/arztebl.2018.0117.

    PMID: 29526182BACKGROUND
  • Rutkowski S, Rutkowska A, Kiper P, Jastrzebski D, Racheniuk H, Turolla A, Szczegielniak J, Casaburi R. Virtual Reality Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Jan 13;15:117-124. doi: 10.2147/COPD.S223592. eCollection 2020.

    PMID: 32021150BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Heba fahmy, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Aliae Hussein, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly allocated to either the intervention or control group in a 1:1 ratio using computer-generated randomization
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial conducted at Chest Department at Assiut University Hospital
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecture of chest diseases

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

January 1, 2024

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

November 21, 2023

Record last verified: 2023-11