Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202502763685954 Date of Registration: 27/02/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intensive versus Normal Rehabilitation Programs in Stable COPD Patients
Official scientific title Intensive versus Normal Rehabilitation Programs in Stable COPD Patients
Brief summary describing the background and objectives of the trial Chronic obstructive pulmonary disease (COPD) is a multifactorial and progressive chronic respiratory non-communicable disease. Management of this disease encompasses a multifaceted approach, Pulmonary rehabilitation is considered a cornerstone treatment in the management of COPD., Each patient exercise according to a protocol especially written for the individual severity of the disease, there is a large debate what is better for each patient an intensive program with 2 sessions per day or one session is effective?, as People with COPD frequently face specific disabling, therefore we have conducted our study to assess if there is a difference between the two programs with one or two sessions per day? And to find out which is beneficial from different views as cost-benefit and functional limitations.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/11/2024
Actual trial start date 17/11/2024
Anticipated date of last follow up 15/01/2025
Actual Last follow-up date 15/01/2025
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 55
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
R265 FMASU
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group pulmonary Rehabilitation programs will receive two sessions per day 3 weeks The program of rehabilitation in the form of limb and chest PR will be designed according to each patient’s medical condition, in the form of range of motion exercise ( active and passive) to all joints of both upper and lower limbs, stretch to both tendo Achilles and shoulders, message to both calf muscles, ankle pump exercise bilateral, chest expansion exercise, respiratory muscle exercise, cough training exercise, trunk–abdominal exercise, graduated strengthening exercise, bedside mobility training exercise, graduated gait training exercise, and graduated stepping training exercise. The patients will be divided randomly into two experimental groups: the second group one session per day. 25
Control Group pulmonary Rehabilitation program one session per day 3 weeks The program of rehabilitation in the form of limb and chest PR will be designed according to each patient’s medical condition, in the form of range of motion exercise ( active and passive) to all joints of both upper and lower limbs, stretch to both tendo Achilles and shoulders, message to both calf muscles, ankle pump exercise bilateral, chest expansion exercise, respiratory muscle exercise, cough training exercise, trunk–abdominal exercise, graduated strengthening exercise, bedside mobility training exercise, graduated gait training exercise, and graduated stepping training exercise this group will receive one session per day 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i) patients above 18 years old. ii) GOLD II and III patients\ iii) Clinically stable patients (i) Over 75 years old (ii)any medical condition that would limit their exercise tolerance (sever cardiac, musculoskeletal, neuromuscular conditions, or recent surgery) (iii)psychiatric conditions or cognitive deficits (iv)history of neoplasia or immunologic diseases Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2024 REC FWA Ain shams university faculty of medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo Egypt Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1-baseline oxygen saturation (SPO2) 3 weeks post intervention
Secondary Outcome Six minutes walking test (6MWT): to assess Functional exercise capacity 3 weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals Abbasya square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hala sabah abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor individual Abbasia Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hala sabah halams@med.asu.edu.eg 0201006720301 20 st 5th stellment new cairo
City Postal code Country Position/Affiliation
Cairo Egypt Ass. Professor
Role Name Email Phone Street address
Public Enquiries Rehab Maher rehabmaher@med.asu.edu.eg 0201223120418 naser city
City Postal code Country Position/Affiliation
Cairo Egypt Asso. Professor
Role Name Email Phone Street address
Scientific Enquiries Samia Rashad smsma313@hotmail.com 0201005856783 masr elgedida
City Postal code Country Position/Affiliation
Cairo Egypt Asso. Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes yes IPD will be shared .upon request, the de-identified IPD will be shared via a secure online platform. Study Protocol 18 month controlled access, all data analyzed will be permitted requesting data by email authors qualifications will decide which request accepted
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 20/02/2025 PACTR Admin Intensive versus Normal Rehabilitation Programs in Stable COPD Patients Intensive versus Normal Rehabilitation Programs in Stable COPD Patients
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 18/02/2025 we have finished the study 17 Nov 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 18/02/2025 we have finished the study 15 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 18/02/2025 we have finished the study 55
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 24/02/2025 this is what we have done in our study group (i) Over 85 years old (ii)any medical condition that would limit their exercise tolerance (sever cardiac, musculoskeletal, neuromuscular conditions, or recent surgery) (iii)psychiatric conditions or cognitive deficits (iv)history of neoplasia or immunologic diseases (i) Over 75 years old (ii)any medical condition that would limit their exercise tolerance (sever cardiac, musculoskeletal, neuromuscular conditions, or recent surgery) (iii)psychiatric conditions or cognitive deficits (iv)history of neoplasia or immunologic diseases
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 20/02/2025 i didn't recognize that i must choose multiple age groups Middle Aged: 45 Year(s)-64 Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 18/02/2025 I did not understand the question at first R265, FMASU
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/02/2025 missed information Primary Outcome, 1-baseline oxygen saturation (SPO2), 3 weeks Primary Outcome, 1-baseline oxygen saturation (SPO2), 3 weeks post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/02/2025 missed information Secondary Outcome, Six minutes walking test (6MWT): to assess Functional exercise capacity, 3 weeks Secondary Outcome, Six minutes walking test (6MWT): to assess Functional exercise capacity, 3 weeks post intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 24/02/2025 the old file was wrong one. but this is the ethical approval for this study TRUE, REC FWA Ain shams university faculty of medicine research ethics committee, Abbasia, Cairo Egypt, Cairo, 11591, Egypt, , 07 Nov 2024, 20226857539, REC-FMASU@med.asu.edu.eg, 32113_30217_4737.pdf TRUE, REC FWA Ain shams university faculty of medicine research ethics committee, Abbasia, Cairo Egypt, Cairo, 11591, Egypt, , 07 Nov 2024, 20226857539, REC-FMASU@med.asu.edu.eg, 32113_30217_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 20/02/2025 i only added the name of the self funding no source, abbasia, Cairo, , Egypt, Self Funded, Hala sabah, abbasia, Cairo, , Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 18/02/2025 missed data collected information on how this data will be made available to other researchers Enrolled patients were randomly divided into 2 matched groups (25 in each group), group I received one rehabilitation session per day, group II received two sessions per day. The duration of the PR program was three weeks for both groups.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 20/02/2025 i write it in wrong way before Enrolled patients were randomly divided into 2 matched groups (25 in each group), group I received one rehabilitation session per day, group II received two sessions per day. The duration of the PR program was three weeks for both groups. yes IPD will be shared , identification date underlying study protocol, study results will be available
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 24/02/2025 correction yes IPD will be shared , identification date underlying study protocol, study results will be available yes IPD will be shared .upon request, the de-identified IPD will be shared via a secure online platform.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 24/02/2025 this is the first age above 18 as adult 18 Year(s) 19 Year(s)