A Women-Focused Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life
NCT Number: NCT06472414
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases
Interventions: BEHAVIORAL: Individualized Counselling Sessions|BEHAVIORAL: Educational Women-Focused Sessions|BEHAVIORAL: Supervised Exercise Training Sessions
Sponsor: University of Lisbon
Collaborators: Fundação para a Ciência e a Tecnologia|Egas Moniz - Cooperativa de Ensino Superior, CRL
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2027-04

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 hypertension/diabetes, 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)

Primary Outcome Measures: Adherence, Number of sessions attended divided by the number of exercise sessions prescribed. Exercise physiologists responsible for the exercise training sessions will register each session attended/missed., End of first month, end of second month, end of third month, end of fourth month, end of fifth month, end of sixth month.
Secondary Outcome Measures: Sociodemographic information, A self-reported online survey will be filled regarding marital, financial, education and work status; distance to the program; previous sports history., At baseline|Self-reported Clinical History, A self-reported online survey will be filled regarding sex-specific and traditional cardiovascular risk factors; current medication; other diseases; orthopaedic limitations; cardiovascular rehabilitation history., At baseline|Medical Information, Medical charts information will be provided directly by participants or by the responsible physician after participants consent. Information regarding type of cardiovascular disease, type of intervention, date of discharge, date of the cardiovascular event, date of the cardiovascular intervention, number of cardiovascular rehabilitation phase 2 sessions attended, will be registered., At baseline|Enrolment, Number of participants who attended at least one exercise session divided by the number of participants who were referred and willing to participate., At 3-months|Change in Cardiorespiratory Fitness, A symptom-limited ramp incremental cardiopulmonary exercise test will be performed by a cardiologist, technician, and exercise physiologist. Subjects will be non-fasting, on regular medication, using a cycle ergometer (CardioWise Ergo Fit) with a breath-by-breath gas analyser (Cardiovit CS-200, Schiller). Resistance will increase by 10-25 W/min at 60 rpm. A twelve-lead ECG will be recorded continuously, and blood pressure measured at baseline, every 2 minutes, peak exercise, and during recovery. Peak oxygen capacity will be the highest VO2 during the final 30 seconds of exercise (mL/kg/min). The ventilatory threshold will be estimated by the V-slope method (mL/kg/min). The respiratory compensation point will be where the ventilation to VCO2 ratio increases after a period of decrease or stasis (mL/kg/min). Peak workload, ventilatory threshold workload, and respiratory compensation point workload will be recorded (Watts). All patients should achieve a respiratory exchange ratio \>1.1., At 6-months|Change in maximal isometric handgrip strength, An exercise physiologist will assess maximal handgrip strength (kg) using a portable hand dynamometer JAMAR plus digital (Sammons Preston, Bolingbrook, IL). The patients will be all positioned according to the American Society of Hand Therapists guidance. Briefly, the handgrip test will be performed with the patients in a seated comfortable position, with the shoulder adducted and close to, but not supported by, the trunk. The elbow of the assessed limb should be flexed to 90 degrees and the forearm should be in a neutral position (halfway between supine and pronation position). A variation of 0-30 degrees in the wrist extension will be allowed. Each subject will attempt 3 maximal measures on both hands alternately. After each attempt, there will be a resting period of 60 seconds that will be used both for recovery and for changing the handgrip dynamometer to the opposite hand. All patients will be instructed not to perform a Valsalva manoeuvre during the tests., At 6-months|Change in physical activity levels, An accelerometer (ActiGraph GT3X+) will be used on the non-dominant wrist, for 24 hours per day, over 7 consecutive days. The accelerometers will be initialised to record at 100 Hz. Data will be downloaded using ActiLife (version 6.13.5) and raw data will be processed in R (package GGIR, version 3.1-1). Time spent in light physical activity, moderate physical activity, vigorous physical activity, moderate to vigorous physical activity (minutes per day and minutes per week) and number of daily steps, will be assessed., At 3-months and at 6-months|Change in sedentary behaviour, An accelerometer (ActiGraph GT3X+) will be used on the non-dominant wrist, for 24 hours per day, over 7 consecutive days. The accelerometers will be initialised to record at 100 Hz. Data will be downloaded using ActiLife (version 6.13.5) and raw data will be processed in R (package GGIR, version 3.1-1). Time spent in sedentary behaviour (hours per day, hours per week, minutes per day, minutes per week, percentage per day), number of sedentary breaks and sedentary bouts, will be assessed., At 3-months and at 6-months|Change in sleep, An accelerometer (ActiGraph GT3X+) will be used on the non-dominant wrist, for 24 hours per day, over 7 consecutive days. The accelerometers will be initialised to record at 100 Hz. Data will be downloaded using ActiLife (version 6.13.5) and raw data will be processed in R (package GGIR, version 3.1-1). Sleep time duration (minutes per day and hours per day) and sleep quality will be assessed., At 3-months and at 6-months|Change in body mass index (BMI), Height (in meters) will be measured to the nearest 0.5 cm with a stadiometer (SECA 287, Hamburg, Germany), body weight (in kilograms) will be measured on a weight scale (SECA 287, Hamburg, Germany) withou shoes and with minimal clothes. BMI will be calculated (kg/m\^2) as weight (kg) divided by the square of the height (m)., At 6-months|Change in body composition, Measurements will be performed in the morning period following a 12 h fast and refraining from caffeine, alcohol, and moderate to vigorous exercise during the last 24h. Bioelectrical impedance analysis (Bodystat Quadscan 4000 Touch) is a simple, non-invasive assessment of hydration and nutrition status. Total fat mass (kg) and percentage, total lean mass (kg) and percentage, fat-free mass index, body fat mass index, total body water percentage, and phase angle will be retrieved., At 6-months|Prevención con Dieta Mediterránea (PREDIMED) to measure Mediterranean diet adherence, This validated questionnaire was developed by The Prevención con Dieta Mediterránea (PREDIMED) study. Each question has a score of 0 or 1, score 1 denoting that the answer was in line with the Mediterranean Diet recommendations. A sum of scores from the 14 questions will be obtained to define whether participants have a low (0-5), medium (6-7), or high (8-14) adherence to the Mediterranean Diet., At 6-months|Behavioural Regulation in Exercise Questionnaire 2 (BREQ-2) to measure change in Behaviour Regulation, The Behavioural Regulation in Exercise Questionnaire 2 (BREQ-2) is a 19-item questionnaire that measures five factors (amotivation, external, introjected, identified and intrinsic motivation) with respect to motivation to exercise with a 5-point Likert scale (0=not true for me, 4=very true for me). Posteriorly, the mean score of the three to four items related to each factor is calculated. Higher, positive scores indicate greater relative autonomy; lower, negative scores indicate more controlled regulation., Baseline, at 3-months and at 6-months|Short Form-36 Health Survey (SF-36) to measure change in Quality of Life, The Short Form-36 Health Survey (SF-36) is a self-assessment health status questionnaire composed of 36 questions about sociodemographic, health, and personal behaviour. It captures the individual's perception of their general health by sorting them into 8 multi-item scales as follows: physical functioning; role/physical; bodily pain; general health; vitality/energy; social functioning; role/emotional; mental health/emotional wellbeing. The items and dimensions in SF-36 were constructed using the Likert method of summated ratings. For all items, a high score defines a more favourable health state. Each item is scored on a 0 to 100 range. Items in the same scale are averaged together to create the 8 scale scores. The SF-36 also provides two important summary measures of health-related quality of life: physical component summary and mental component summary scales. The strength of both scales lies in their ability to distinguish a physical from a mental outcome., At 6-months|Cardiovascular Rehabilitation Barriers Scale (CRBS) to measure change in barriers to cardiovascular rehabilitation programs, The Cardiovascular Rehabilitation Barriers Scale (CRBS) is composed of 21 items rated on a 5-point Likert-type scale that ranges from 1=strongly disagree to 5=strongly agree. Higher scores indicate greater barriers to patient enrolment or participation in a cardiovascular rehabilitation program., Baseline, at 3-months and at 6-months|Hospital Anxiety and Depression Scale (HADS) to measure change in Anxiety and Depression, The Hospital Anxiety and Depression Scale (HADS) is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A higher score indicates higher distress., At 6-months