NCT07020182

Brief Summary

The study aimed to identify the effect of early pulmonary rehabilitation in elderly patients with Acute exacerbation (AE) of COPD (AECOPD) in exercise tolerance, dyspnea, sleep quality, fatigue, and time to discharge from hospital.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

May 10, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

Elderly patients with acute exacerbation of COPD

Outcome Measures

Primary Outcomes (1)

  • Exercise tolerance

    The 6 minute walk test(6MWT)in meter to asses exercise tolerance

    The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks

Secondary Outcomes (3)

  • Dyspnea

    The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks

  • Length of hospital stay(LOS)

    The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks

  • Fatigue level

    The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks

Study Arms (2)

Group A will perform physical therapy program

EXPERIMENTAL

Study group In this study we will study the impact of exercise training include breathing exercise, low-load resistance exercise (15%-30% of 1 repetition maximum (1-RM) as tolerated), aerobic training in the form of walking exercise under supervision of physiotherapist.In patients exercise tolerance, dyspnea, fatigue, and time to discharge from hospital. The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks

Other: physical therapy program

Group B will the control group

NO INTERVENTION

control group

Interventions

Group A will performed a physical therapy program that completed two daily sessions till discharge from the hospital .Exercise training starts from randomisation until hospital discharge,and administered twice per day, seven times per week. The study will be start from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks

Group A will perform physical therapy program

Eligibility Criteria

Age65 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with acute exacerbation of COPD in both gender
  • Patient older than 65 years
  • Patient with clear consciousness
  • Patients had been diagnosed with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema

You may not qualify if:

  • Patient with systolic blood pressure lower than 90 mmHg
  • Patient with an unstable psychological status, hemoptysis, pneumothorax, pulmonary edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine for Girls- Al-Azhar-University, Cairo, Egypt

Cairo, 02, Egypt

Location

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

  • Mohammed, phd

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Mohammed, Phd -university lecturer

CONTACT

Marwa Mohammed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The codes were determined by using serially numbered block size will be kept in sealed and opaque envelopes in a locked office
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective supervised RCT (Randomized Controlled Trial) will be done include elderly COPD patients assigned randomly into two groups; Group A performed physical therapy program, and Group B is control group completed two daily sessions from day 1 of hospital admission till discharge from the hospital.The study duration will be 12 weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy,Beni-suef University

Study Record Dates

First Submitted

May 10, 2025

First Posted

June 13, 2025

Study Start

June 10, 2025

Primary Completion

September 10, 2025

Study Completion

September 15, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations