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.: PACTR202203596906592 Date of Approval: 23/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title exercise training and chronic heart failure
Official scientific title Anti remodeling effect of aerobic interval and inspiratory muscle training on atrial fibrillation associated with chronic heart failure
Brief summary describing the background and objectives of the trial Atrial fibrillation, especially when persistent or permanent, is present in at least 20 % of patients with chronic heart failure (CHF), with prevalence increasing with the severity of the syndrome. It is associated with a poorer prognosis in patients with than those without CHF, and among patients with a higher incidence of more severe cardiac arrhythmias.(Cornelis et al,2018). Physical activity and exercise training improve symptoms and can have antiarrhythmic effects in individuals with AF and may be protective against the development of AF. In patients with chronic heart failure with reduced ejection fraction exercise training is associated with improved exercise capacity, improved quality of life, and reduced all-cause mortality and hospitalization(Luo et al, 2017). The present study will investigate the effect of combined High-intensity interval training and inspiratory muscle training in managing atrial fibrillation patients with chronic heart failure.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) protocol was approved and recruitment will start
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 12/03/2022
Actual trial start date 12/03/2022
Anticipated date of last follow up 13/08/2022
Actual Last follow-up date 15/09/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL https://www.cfrjournal.com/articles/exercise-training-heart-failure-patients-persistent-atrial-fibrillation-practical-approach
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training group I)inspiratory muscle training: Inspiratory muscle training at 30% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 6 months. MIP will be measured every week as a follow up to ensure the maintenance of training load on 30% of MIP. 2)Interval aerobic training: A) Warming up:Each session started with a 5-minute bicycling warm up at 30%-40%of HRR obtained from ECG telemetry during 6MWT. b) Active phase: • Mode: High-intensity interval aerobic training (HIIT). • Intensity:With high-intensity intervals of 80%- 90%of heart rate reserve (HRR)separated by moderate-intensity active recovery 50% -70% of (HHR).Heart rate reserve is (peak heart rate- resting heart rate) both obtained from ECG telemetry device so Target HR =80% -90% (HRR)+ resting heart rate (Keteyian et al, 2019)(Melo et al,2019) • Duration: starting with 25 minutes progress to 35 minutes Patients will start with 4×2 interval training (4 indicate the number of intervals and 2 indicates the number of minutes) of high intensity at 80% HHR ,these intervals separated by 3 intervals of 2 min of recovery at 50% of HRR .The progression will be every 2 weeks of training to completing 4-min of 4 intervals at 85-90% HRR, separated by 3 min at 50% - 70% HRR.(Wewege et al,2018) 5 months I)inspiratory muscle training: Inspiratory muscle training at 30% of maximal inspiratory pressure for 30 minutes/ session, 3 days a week, for 6 months. MIP will be measured every week as a follow up to ensure the maintenance of training load on 30% of MIP. 2)Interval aerobic training: A) Warming up:Each session started with a 5-minute bicycling warm up at 30%-40%of HRR obtained from ECG telemetry during 6MWT. b) Active phase: • Mode: High-intensity interval aerobic training (HIIT). • Intensity:With high-intensity intervals of 80%- 90%of heart rate reserve (HRR)separated by moderate-intensity active recovery 50% -70% of (HHR).Heart rate reserve is (peak heart rate- resting heart rate) both obtained from ECG telemetry device so Target HR =80% -90% (HRR)+ resting heart rate (Keteyian et al, 2019)(Melo et al,2019) • Duration: starting with 25 minutes progress to 35 minutes Patients will start with 4×2 interval training (4 indicate the number of intervals and 2 indicates the number of minutes) of high intensity at 80% HHR ,these intervals separated by 3 intervals of 2 min of recovery at 50% of HRR .The progression will be every 2 weeks of training to completing 4-min of 4 intervals at 85-90% HRR, separated by 3 min at 50% - 70% HRR.(Wewege et al,2018) 25
Control Group control group medications only and follow up at the start and end of the trial 5 months Medications 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participated patients will be • Male Patients aged from 40 to 55 years old • Did not participate in any exercise program before • Controlled permanent atrial fibrillation (the ventricular rate at rest<100-110 beat /minute) • Class II and class III chronic heart failure according to NYHA classification. Patients who meet one of the following criteria will be excluded • Class I and IV CHF. • Decompensated heart failure • Uncontrolled atrial fibrillation • Implanted pacemaker • Patients with chronic chest diseases. • Primary valvular disease • Clinically significant peripheral vascular disease • Severe anemia • Exercise-induced angina, st segment changes or exercise induce AV block • Patients with chronic renal failure. • Any cognitive impairment that interferes with prescribed exercise procedures • Musculoskeletal or neurological limitation to physical exercise • Any patient enrolled in an anther research study for at least 30 days Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 55 Year(s) Male
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 14/10/2020 Ethical committee board at National Heart Institute and Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Giza Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Echocardiography , 2- Maximal inspiratory pressure Echocardiography will be measured at the beginning and at the end of the trial. Inspiratory pressure will also measured at the beginning and at the end , in addition to every week to readjus 30
Secondary Outcome Six minute walk distance , short form health survey quality of life , atrial fibrillation specific questionnaire , peak oxygen consumption At the beginning and at the end of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eldemardish Ein Shams cardiac rehabilitation center and National Heart Institute outpatient clinic Giza and Cairo Governorates Giza and Cairo Governorates Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mahmoud Ibrahim Mohammed the Principal investigator Elmaadi , Cairo Cairo 11728 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Doctrol thesis at Faculty of Physical Therapy Ahmed Elzayat , Giza Giza Governorate Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Mahmoud dr.mahmoud.ibrahim2019@gmail.com 01142998414 Elmaade , Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer at Faculty of Physical Therapy Physical Therapy Department for Cardiovascular Respiratory Disorders and Geriatrics Beni Suef University
Role Name Email Phone Street address
Public Enquiries Zeinab Helmy helmy.zeinab@gmail.com 01114773311 Elmanail , Giza
City Postal code Country Position/Affiliation
Giza Egypt Professor at Faculty of Physical Therapy Cairo University Physical Therapy department for Cardiovascular Respiratory Disorders and Geriatrics
Role Name Email Phone Street address
Scientific Enquiries Sherin Mehani drsherinm@gmail.com 01003378217 Beni-Suef
City Postal code Country Position/Affiliation
BeniSuef Egypt Dean of Faculty of Physical Therapy Beni Suef University and Professor at Physical Therapy department for Cardiovascular Respiratory Disorders and Geriatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication, No end date Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose For individual participant metaanalysis URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website. Study Protocol Immediately following publication, No end date There will be controlled access for study protocol and brief summary for results
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL link to protocol file(s) with version and date. This will apply when the protocol has wither been published in a journal or on an institutional website. 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