Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472414
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-11
Brief Title:
A Women-Focused Cardiovascular Rehabilitation Program on Adherence Health Related Physical Fitness and Quality of Life
Sponsor:
University of Lisbon
Organization:
University of Lisbon
Study Overview
Official Title:
Effects of a Women-Focused Maintenance Cardiovascular Rehabilitation Program on Adherence Health Related Physical Fitness and Quality of Life a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiovascular disease CVD remains leader of global causes of death worldwide and recent documented trends show a rise in acute myocardial infarction in younger women Compared to men women have a higher cardiovascular risk due to hypertension dyslipidaemia diabetes mellitus obesity physical inactivity and a sedentary lifestyle Plus they have additional sex-specific cardiovascular risk factors such as gestational hypertensiondiabetes preterm delivery premature menopause and polycystic ovary syndrome
Cardiovascular rehabilitation CR is a Class I level A clinical practice guideline recommendation multidisciplinary secondary prevention program that has been shown to reduce cardiovascular mortality rehospitalization and improve quality of life Despite all established benefits CR continues to be under referred to women compared to men with lower enrolment rates and lower adherence to exercise sessions The reasons for the underuse of CR by women and the main barriers have been widely studied Thus sex-specific implementation strategies have been developed to improve adherence however the efficacy claims of these interventions are equivocal as some studies revealed no significative difference regarding adherence between different exercise delivery modes and mixed-sex programs whereas others revealed greater preference towards women-only programs
Few randomized controlled trials RCT examined the efficacy of CR programs tailored to women in adherence enrolment functional capacity physical activity body composition and quality of life Importantly to the investigators knowledge no RCTs used counselling sessions women-focused educational sessions personalized follow-ups and supervised exercise sessions as adherence strategies in maintenance CR community programs
The goal of this RCT is to test whether a women-focused maintenance CR community program increases adherence compared to a standard care Thus the investigators hypothesized that
The women-focused group will have greater adherence to the CR community program main outcome
Participants will
Be assessed at baseline at 3-months and at 6-months
Enrol in a supervised community-based maintenance CR program
Receive individually prescribed exercise sessions both groups a tailored package consisting of individual counselling sessions and educational sessions women-focused group
Cardiovascular rehabilitation CR is a Class I level A clinical practice guideline recommendation multidisciplinary secondary prevention program that has been shown to reduce cardiovascular mortality rehospitalization and improve quality of life Despite all established benefits CR continues to be under referred to women compared to men with lower enrolment rates and lower adherence to exercise sessions The reasons for the underuse of CR by women and the main barriers have been widely studied Thus sex-specific implementation strategies have been developed to improve adherence however the efficacy claims of these interventions are equivocal as some studies revealed no significative difference regarding adherence between different exercise delivery modes and mixed-sex programs whereas others revealed greater preference towards women-only programs
Few randomized controlled trials RCT examined the efficacy of CR programs tailored to women in adherence enrolment functional capacity physical activity body composition and quality of life Importantly to the investigators knowledge no RCTs used counselling sessions women-focused educational sessions personalized follow-ups and supervised exercise sessions as adherence strategies in maintenance CR community programs
The goal of this RCT is to test whether a women-focused maintenance CR community program increases adherence compared to a standard care Thus the investigators hypothesized that
The women-focused group will have greater adherence to the CR community program main outcome
Participants will
Be assessed at baseline at 3-months and at 6-months
Enrol in a supervised community-based maintenance CR program
Receive individually prescribed exercise sessions both groups a tailored package consisting of individual counselling sessions and educational sessions women-focused group
Detailed Description:
Participants will be recruited from the main public hospitals in the Lisbon area with phase II CR programs such as Unidade Local de Saúde ULS Santa Maria ULS São José and ULS Lisboa Ocidental after physician referral or from cardiology appointments Phone calls face-to-face contact CR hospital team meetings social media and flyers will be used
Posteriorly the CR cardiologist will assess the clinical exams and confirm eligibility criteria After informed consent is interpreted and signed participants will be assessed at the Cardiovascular Exercise and Rehabilitation Laboratory a research unit from the Cardiovascular Centre of the University of Lisbon in one morning approximately 2 hours for the following
1 body composition through bioimpedance
2 clinical and demographic information with questionnaires
3 behaviour regulation through BREQ-2 questionnaire
4 quality of life with SF-36 questionnaire
5 cardiovascular rehabilitation barriers with CRBS questionnaire
6 anxiety and depression with HADS questionnaire
7 mediterranean diet adherence with PREDIMED questionnaire
8 sleep quality with PSQI questionnaire
9 handgrip strength through dynamometer
10 functional capacity through cardiopulmonary exercise testing
11 physical activity with accelerometer
At 3 months only physical activity BREQ-2 CRBS and PSQI will be assessed
In the same morning if no contra indications to exercise training appear at baseline assessments participants will be randomly assigned randomization will be generated by computer randomizerorg in blocks by the principal investigator to one of two groups
1 Control A standard care phase III cardiovascular rehabilitation CR program
2 Intervention Women-focused CR standard care
Both groups will receive the standard care phase III CR program consisting of supervised exercise training sessions at the Cardiovascular Rehabilitation Centre of the University of Lisbon CRECUL These sessions will be prescribed according to the FITT principle frequency intensity time type and to the European Society of Cardiology exercise prescription guidelines Independently of delivery format face to face or online participants will exercise 2 or 3 timesweek 60 minutessession on non-consecutive days for 6 months and supervised by exercise physiologists Participants will be able to choose the schedule they would like to attend according to the program vacancies and the participants availability Participants will also have the possibility to attend meditation classes in an online format once per week
The intervention group in addition will receive four individualized counselling sessions
1 after baseline assessments
2 after 1-month of intervention where barriersfacilitators will be discussed
3 after 3-months assessments to check their feelings towards the program update goals and if new strategies are needed
4 after 6-months assessments to discuss results difficulties perceived plan the future steps and clarify any existing doubts
These sessions will be structured according to the tools and methodology provided by the Portuguese Directorate General of Health Behavioural Change Counselling Manual and Support Tools for Brief Counselling to Promote Physical Activity and delivered by a certified exercise physiologist Besides this the intervention group will also receive 5 women-focused educational sessions pre-record by experts according to the theme in a digital format placed in an online platform and made available at the end of each month After completing the 6-months assessments the control group will have the possibility to receive the individualized sessions and the women-focused educational sessions
To improve retention the following strategies will be implemented
Participants will know that the study is completely voluntary and all data collected will be confidential
Participants will be informed that all analyses and exams will be free of charge and important to assess their health status and safety
The importance of this type of program for an optimal recovery and improved quality of life will be explained
Ensure that physical exercise sessions will be supervised by specialized exercise physiologists and prescribed according to their needs and clinical condition
Participants will receive behavioural modification strategies through individualized brief counselling sessions
Inform participants that they will receive a final report with the assessments results
Statistical analyses Sociodemographicclinical characteristics will be analysed using t-tests chi-square if appropriate and nonparametric alternative in case of a non-normalized distribution Generalized estimation equations will be used to estimate the effects between and within-group on primary and secondary outcomes Intention-to-treat analysis will be performed Statistical analysis will be performed using SPSS version 290 IBM SPSS Statistics with significance set at p005 Education age and time since CVD diagnosis will be used as co-variables in statistical analysis models
Posteriorly the CR cardiologist will assess the clinical exams and confirm eligibility criteria After informed consent is interpreted and signed participants will be assessed at the Cardiovascular Exercise and Rehabilitation Laboratory a research unit from the Cardiovascular Centre of the University of Lisbon in one morning approximately 2 hours for the following
1 body composition through bioimpedance
2 clinical and demographic information with questionnaires
3 behaviour regulation through BREQ-2 questionnaire
4 quality of life with SF-36 questionnaire
5 cardiovascular rehabilitation barriers with CRBS questionnaire
6 anxiety and depression with HADS questionnaire
7 mediterranean diet adherence with PREDIMED questionnaire
8 sleep quality with PSQI questionnaire
9 handgrip strength through dynamometer
10 functional capacity through cardiopulmonary exercise testing
11 physical activity with accelerometer
At 3 months only physical activity BREQ-2 CRBS and PSQI will be assessed
In the same morning if no contra indications to exercise training appear at baseline assessments participants will be randomly assigned randomization will be generated by computer randomizerorg in blocks by the principal investigator to one of two groups
1 Control A standard care phase III cardiovascular rehabilitation CR program
2 Intervention Women-focused CR standard care
Both groups will receive the standard care phase III CR program consisting of supervised exercise training sessions at the Cardiovascular Rehabilitation Centre of the University of Lisbon CRECUL These sessions will be prescribed according to the FITT principle frequency intensity time type and to the European Society of Cardiology exercise prescription guidelines Independently of delivery format face to face or online participants will exercise 2 or 3 timesweek 60 minutessession on non-consecutive days for 6 months and supervised by exercise physiologists Participants will be able to choose the schedule they would like to attend according to the program vacancies and the participants availability Participants will also have the possibility to attend meditation classes in an online format once per week
The intervention group in addition will receive four individualized counselling sessions
1 after baseline assessments
2 after 1-month of intervention where barriersfacilitators will be discussed
3 after 3-months assessments to check their feelings towards the program update goals and if new strategies are needed
4 after 6-months assessments to discuss results difficulties perceived plan the future steps and clarify any existing doubts
These sessions will be structured according to the tools and methodology provided by the Portuguese Directorate General of Health Behavioural Change Counselling Manual and Support Tools for Brief Counselling to Promote Physical Activity and delivered by a certified exercise physiologist Besides this the intervention group will also receive 5 women-focused educational sessions pre-record by experts according to the theme in a digital format placed in an online platform and made available at the end of each month After completing the 6-months assessments the control group will have the possibility to receive the individualized sessions and the women-focused educational sessions
To improve retention the following strategies will be implemented
Participants will know that the study is completely voluntary and all data collected will be confidential
Participants will be informed that all analyses and exams will be free of charge and important to assess their health status and safety
The importance of this type of program for an optimal recovery and improved quality of life will be explained
Ensure that physical exercise sessions will be supervised by specialized exercise physiologists and prescribed according to their needs and clinical condition
Participants will receive behavioural modification strategies through individualized brief counselling sessions
Inform participants that they will receive a final report with the assessments results
Statistical analyses Sociodemographicclinical characteristics will be analysed using t-tests chi-square if appropriate and nonparametric alternative in case of a non-normalized distribution Generalized estimation equations will be used to estimate the effects between and within-group on primary and secondary outcomes Intention-to-treat analysis will be performed Statistical analysis will be performed using SPSS version 290 IBM SPSS Statistics with significance set at p005 Education age and time since CVD diagnosis will be used as co-variables in statistical analysis models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None