Manipulating Exercise Intensity and Affective Responses for Cardiac Rehabilitation Program Acute Coronary Syndrome Patients

NCT07105943 | Recruiting DMC

• 1 other identifier: Instituto Politécnico Leiria
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if pleasure-oriented exercise intensity manipulation increases physical activity (PA) behavior in patients who have suffered acute coronary syndrome during a cardiac rehabilitation program. The main question it aims to answer is:

• the manipulation of exercise intensity performed to produce more pleasure and arousal will impact the PA behavior? Researchers will compare the PA levels and affective responses to see if the manipulation of exercise intensity guided to pleasure and arousal works to increase PA behavior compared to the control group who will follow a conventional exercise program. Participants will do:
• sixteen individualized hospital exercise sessions (two per week) and complementary physical activity program integrated into their daily life
• be evaluated before and at the end of the exercise sessions and after 3 months

Conditions

Affect and Exertion During and Post-exercise

Keywords

acute coronary syndrome; cardiac rehabilitation; physical activity; affective response; motivation

Outcome Measures

Primary Outcomes (4)

• Physical activity levels by International Physical Activity Questionnaire - Short Form

  International Physical Activity Questionnaire - Short Form: physical activity will be assessed by a continuous variable, expressed in MET-minutes per week. It will be applied in order to evaluate the same week of accelerometry.

  At baseline (the week before phase 2 cardiac rehabilitation program), end of the intervention (first week after the intervention) and at 3 months after it

• Affective responses in exercise sessions phase 2 cardiac rehabilitation program - Felt Arousal Scale

  Felt Arousal Scale is a 6-point scale ranging from 1 ("Low arousal") to 6 ("High arousal") that assesses perceived activation

  During all exercise sessions (twice a week for 8 weeks) will be administered at 10-min intervals during the aerobic activity; immediately after the fourth and eighth resistance exercises set and in the last 15 sec of the set of the fifth stretch exercise

• Physical activity levels by accelerometry

  We will use the ActiGraph® GT3X+ (Pensacola, FL) accelerometer. The researcher will distribute the accelerometers to all participants, that will be instructed to wear the device on an elastic belt around their waist on the right side for seven consecutive days, taking it off only for water-based activities (e.g., shower and swimming) and sleep. Participants will be asked to carry out their usual activities during data collection. The cut points and wear time validation criteria will be used to define the time spent in each intensity period and to define a valid register. A day will be considered valid with at least 600 minutes of use, and each participant will have to present at least four valid days, including a at least one weekend day to be included in the analysis. Compliance with PA recommendations for public health will be assessed according to EAPC recommendations (150 min/week of MVPA defined as ≥ 21.4 min/day).

  At baseline (the week before phase 2 cardiac rehabilitation program), end of the intervention (first week after the intervention) and at 3 months after it

• Affective responses in exercise sessions phase 2 cardiac rehabilitation program - Feeling Scale

  Feeling Scale is an 11-point scale ranging from -5 ("Very bad") to +5 ("Very good"), which assesses the affective valence (how one feels at that given moment)

  During all exercise sessions (twice a week for 8 weeks) will be administered at 10-min intervals during the aerobic activity; immediately after the fourth and eighth resistance exercises set and in the last 15 sec of the set of the fifth stretch exercise

Secondary Outcomes (13)

• Participation in the complementary physical activity program

  In the 8 weeks of the intervention

• Anticipated affective response

  5 minutes before the exercise sessions 1, 8 and 16 during the intervention (exercise sessions are twice a week for 8 weeks)

• Final remembered affect to the previous exercise session

  5 minutes after exercise sessions 1, 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks)

• Intention to continue exercising

  5 min before session 1 and 5 min after session 16 during intervention (exercise sessions are twice a week for 8 weeks). At the end of the intervention (first week after the intervention) and at 3 months after it

• Exercise habit

  5 min before session 1 and 5 min after session 16 during intervention (exercise sessions are twice a week for 8 weeks). At the end of the intervention (first week after the intervention) and at 3 months after it

Other Outcomes (3)

• Resting blood pressure

  Before and after all exercise sessions during the intervention (exercise sessions are twice a week for 8 weeks).

• Heart rate during exercise

  During all the exercise sessions during the intervention (exercise sessions are twice a week for 8 weeks).

• Perceptions of effort

  During all exercise sessions the Borg Scale will be administered at 10-min intervals during the aerobic activity; immediately after the set of the fourth and eighth resistance exercises, and in the last 15 sec of the fifth stretch exercise

Study Arms (2)

Control

ACTIVE COMPARATOR

Other: Control

Experimental

EXPERIMENTAL

Other: Experimental

Interventions

Experimental OTHER

As for the experimental group, in the 16 individualized training sessions (two per week), attention will be given to exercise intensity assessment and manipulation, with the goal of optimizing the affective experience of exercise, while also respecting minimum and maximum intensity thresholds as proposed by the EAPC (self-selected intensity within individually defined limits). The pre-exercise evaluation, the number of sessions, and methodological approach will be the same to the control group. In this group it will be presented some awareness of the potential of choosing fun and pleasant activities.

Experimental

Control OTHER

The intervention will be implemented in the 8 weeks phase 2 cardiac rehabilitation program. Both groups will receive a pre-exercise evaluation and 16 individualized training sessions (two per week) based on FITT-VP principles and according to the European Association of Preventive Cardiology (EAPC) guidelines. A complementary physical activity program integrated into their daily life will be prescribed. It will receive regular briefing sessions regarding the health-related benefits of exercise. After these sessions, it will be recommended to maintain physical activity aiming to reach at least 150 min/week of moderate intensity PA.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• left ventricular ejection fraction (LVEF) \< 40% at rest
• uncontrolled arrythmias (e.g., complex ventricular arrhythmias, atrial fibrillation or flutter with rapid ventricular response, second-degree atrioventricular block Mobitz type II, or third-degree atrioventricular block)
• presence of an implantable cardiac device
• symptomatic peripheral arterial disease
• comorbidities that may interfere with the ability to perform the exercise program safely.

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead
• Universidade Lusófona de Humanidades e Tecnologias: collaborator
• Centro Hospitalar de Leiria: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (2)

Unidade Local de Saúde da Região de Leiria

Leiria, 2410-197, Portugal

NOT YET RECRUITING

Hospital de Leiria

Leiria, Portugal

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Central Study Contacts

Filipa Januario, MMed

CONTACT

+351817073; filipa.januario@ulsrl.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator Member

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 6, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)