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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Politécnico de Leiria

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients older than 18 years

diagnosis of ACS within the past 12 months who have not previously participated in a CR program

patients classified as low-risk (Class B) according to the American Heart Association: (a) New York Heart Association (NYHA) class I or II, (b) exercise capacity greater than 6 METs, (c) no evidence of heart failure, (d) no signs of myocardial ischemia or angina at rest or during exercise testing at or below 6 METs, (e) appropriate systolic blood pressure response during exercise, and (f) absence of sustained or non-sustained ventricular tachycardia at rest or during exercise.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control

    Other intervention

    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.

  • Experimental

    Other intervention

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

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

Time frame
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
3

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).

Time frame
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
4

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)

Time frame
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

1

Participation in the complementary physical activity program

minutes-week of physical activity

Time frame
In the 8 weeks of the intervention
2

Anticipated affective response

Anticipated affective response to a future exercise session measured with the adaptation of the Empirical Valence Scale will be used to assess anticipated affective response to exercise sessions. This instrument uses 15 empirically spaced verbal anchors ranging from -100 ("Most unpleasant imaginable") to +100 ("Most pleasant imaginable"). Participants will respond to the question "Considering the workout you are about to begin (previously explained/remembered), how do you think it will make you feel?".

Time frame
5 minutes before the exercise sessions 1, 8 and 16 during the intervention (exercise sessions are twice a week for 8 weeks)
3

Final remembered affect to the previous exercise session

Remembered affect of previous exercise session measured with the Visual Analog Scale A Visual Analog Scale (VAS) will be used to assess remembered exercise pleasure/displeasure. Participants will be asked to rate "How did your last workout make you feel?". This scales ranges from +100 ("very pleasant") to -100 ("very unpleasant").

Time frame
5 minutes after exercise sessions 1, 8 and 16 during intervention (exercise sessions are twice a week for 8 weeks)
4

Intention to continue exercising

The behavioral intention will be assessed using three items (e.g., "I will continue to practice physical exercise in the next 6 months as I recently practiced \[with or without personal trainer\] or in a very similar way (same type, frequency, duration, and intensity"). Responses are entered using a 7-point ordinal scale ranging from 1 ("Absolutely not") to 7 ("Absolutely yes").

Time frame
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

1

Resting blood pressure

Resting blood pressure (mmHg) - systolic and diastolic. It will be tested on the right upper limb of the seated patient.

Time frame
Before and after all exercise sessions during the intervention (exercise sessions are twice a week for 8 weeks).
2

Heart rate during exercise

Heart rate will be monitored using a telemetry system

Time frame
During all the exercise sessions during the intervention (exercise sessions are twice a week for 8 weeks).
3

Perceptions of effort

Perceptions of effort assessed by Borg Rating of Perceived Exertion Scale 15-point (Borg Scale)

Time frame
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

Sponsors and contacts

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Instituto Politécnico de Leiria

Lead sponsor

Universidade Lusófona de Humanidades e Tecnologias

Collaborator

Centro Hospitalar de Leiria

Collaborator

Rede de Investigação em Saúde

Collaborator