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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202476383975 Date of Approval: 28/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFICACY OF EARLY MOBILIZATION AFTER RECENT DECOMPENSATION OF HEART FAILURE DURING PHASE I CARDIAC REHABILITATION
Official scientific title EFFICACY OF EARLY MOBILIZATION AFTER RECENT DECOMPENSATION OF HEART FAILURE DURING PHASE I CARDIAC REHABILITATION
Brief summary describing the background and objectives of the trial Little attention is paid to the role of physiotherapy supervised mobilization program in phase one cardiac rehabilitation despite its importance. The aim of this study is to investigate the efficacy of early start supervised mobilization program during hospitalization phase after acute decompensated HF.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/02/2021
Actual trial start date
Anticipated date of last follow up 03/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early mobilization Within 3 days of hospital discharge to discharge day This group will receive early supervised structured mobilization protocol plus the usual care (standard medical treatment ± respiratory exercises) 20
Control Group Control group From the day of admission to discharge day This group will only receive the usual care (standard medical treatment ± respiratory exercises) 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Recently decompensated heart failure due to acute exacerbation of chronic heart failure. Clinical stability Age from 45 to 60 Both males and females 1)Ongoing cardiogenic shock with need of intravenous inotropic therapy 2)Presence of myocardial necrosis markers and presence of acute ischemia on the electrocardiogram such as ST segment elevation or depression 3)Motor abnormality that compromise locomotion 4)Altered level of consciousness 5)Patient who underwent surgery at hospitalization time 6)Critically ill condition 7)Acute and critical dysrhythmias Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 05/01/2021 the Ethics Committee of Scientific Research of the Faculty of Physical Therapy at Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayyat St., Dokki, Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 6-minute walk test at discharge
Primary Outcome Barthel Index at baseline and discharge
Primary Outcome N-terminal prohormone of brain natriuretic peptide (NT-proBNP) At baseline and discharge
Secondary Outcome Length of hospital stays At discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr Alainy Hospital Kasr Alainy street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Aya Elshennawy Cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Kasr Alainy Hospital Kasr Alainy street Giza Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad Ahmad ahmed.mahdy@pt.cu.edu.eg 002001007056624 Abdeen-Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of cardiopulmonary physical therapy at Cairo University
Role Name Email Phone Street address
Public Enquiries Aya Ebrahim Dr.Aya_ebrahime@yahoo.com 0020010098811085 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Senior Physiotherapist at Kasr Akainy Hospital
Role Name Email Phone Street address
Scientific Enquiries Ahmad Ahmad ahmed.mahdy@pt.cu.edu.eg 002001007056624 Adeen-Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assitant professor of cardiopulmonary Physical Therapy at Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in heart failure Statistical Analysis Plan Following publication Not applicable
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