Clinical trial NCT05416593: Exploring the Impact of Individualized Pleasure-Oriented Exercise Sessions in a Health Club Setting
Official title: Exploring the Motivational Impact of Individualized Pleasure-Oriented Exercise Sessions in a Health Club Setting: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affect
Keywords: Affect
Affective response
Exercise
Affective determinants
Circumplex model
Lead sponsor: Grupo Lusófona
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A call for an exercise prescription aiming at pleasure promotion has been proposed by several authors. This entails that current exercise prescription guidelines are heavily focused on a dose-response relation derived from an effectiveness (e.g., fitness gains) and safety of the prescription (e.g., reduced risk of injury for the general population) standpoint. Despite its relevance, this bipartite or biomedical approach (e.g., rationale for a given dose of a drug and expected outcome) tends to overlook other relevant variables that are needed for, for example, behavior maintenance, or individual preferences. Although some flexibility of this rationale may account for personal differences, how to adequately adjust the training variables to individual characteristics is still poorly explored or even expressed.

The call for a tripartite exercise prescription reflects the bout of evidence that supports the relevance of pleasurable experiences in exercise and their impact on adherence. Thus, besides an effective and safe program, contemplating how to assess and promote exercise-related pleasurable experiences are paramount. As stated in 2011 on the ACSM position stand, affect-regulation did not behold the necessary evidence to be a primary method of exercise prescription, although affect assessment (e.g., through the feeling scale) was proposed to be relevant for exercise intensity self-regulation. A decennial look at the ACSM exercise guidelines shows that although presenting an advancement in affect-related behavioral strategies and theories, no clear indications on operational instruments for assessment and admeasurement of affect are presented depicts a barrier to an adequate advancement in this matter. This can be seen, for example, in ACSM principles for exercise prescription (Frequency, Intensity, Time, and Type; FITT). Although supporting the use of affect regulation for exercise promotion and maintenance, the FITT is not based on a previous (e.g., preexercise evaluation) or in-session affective assessment, and more importantly, does not address how to adjust exercise prescription/supervision aiming to improve the pleasure/displeasure relation.

Detailed description: Background and rationale From a public health standpoint, gyms and health clubs are one of the most relevant contexts of supervised exercise practice, targeting millions of individuals worldwide. However, exercise adherence has proven to be a challenge in the last 20 years. Several indicators show high attrition rates (i.e., clients' dropout in a given period) in these contexts, particularly in the first 6 months.

Individual physical activity promotion can be challenging as it reflects several aspects of a complex human behavior. Many psychological theories and strategies have been used to address this issue, albeit with differentiated results. These are usually based on cognitivist assumptions and have shown small to moderate effects on exercise adherence. However, in recent years, exercise psychology started to shift attention to other constructs that can help expand the predictive value of current theoretical models. Particularly, affective processes (e.g., emotions, mood) have been highlighted as relevant when trying to understand or predict behavior, and a call for a new era - the affectivism - is emerging. This reflects a new parading resulting from decades of evidence in which affective processes can be seen as outcomes, but also as relevant constructs that can expand the understanding of current behavioral strategies and theories.

For example, the latest edition of the American College of Sports Medicine (ACSM) guidelines presented an expanded chapter addressing behavioral theories for increasing physical activity, which, besides the most commonly used (e.g., self-efficacy, self-determination theory, theory of planned behavior), now explores affect regulation as a product of non-conscious motivational processes (e.g., dual-process theories), and the automatic associations between behavior and previous affective response (i.e., remembered affect).

Affective determinants in exercise and the role of exercise intensity

Affect can be understood as an umbrella term that encompasses (1) the most general valenced experiential responses (e.g., pleasure/displeasure; good/bad), termed basic affect or core affect, and (2) emotion and mood, which reflects appraisal processes of basic affect, and are usually called distinct affective states. Several theories and models have been developed in recent years that reflect this conceptualization and the evidence of affect-related constructs, as is the case, for example, of the Affective-Reflective Theory of physical inactivity and exercise (ART); the Physical Activity Adoption and Maintenance (PAAM) model; the Theory of Effort Minimization in Physical Activity (TEMPA), and the Affect and Health Behavior Framework (AHBF).

In the broader look given by the AHBF, the affective response (i.e., how one feels while performing an activity or immediately after completing the activity; core affect), triggers a set of influences that can, via an automatic or reflective affect processing, influence motivation, goals, behavioral intentions and, ultimately, the exercise behavior. As shown in some research, the affective response during exercise has demonstrated to be a determinant of future behavior, and core affective valence and activation the most relevant aspects in this matter. This seems to be grounded in hedonic assumptions (i.e., pursuing pleasure and avoiding displeasure or pain), in which positive (and regular) shifts in affective valence and/or activation tend to increase the likelihood of future exercise behavior, and a negative shift may have an opposite influence.

Regarding exercise characteristics that may influence the affective response, exercise intensity stand out as the most relevant. Current evidence suggests that people present distinct responses as intensity increases. Generally, aerobic activities intensities below the ventilator threshold depict similar patterns among exercisers, given that an increase in intensity usually corresponds to an increase in the pleasurable response. After the ventilator threshold, inter-individual variability marks how soon or accentuated the pleasure decline will be manifested. For resistance training, some evidence also indicates that increases in intensity (e.g., Repetition Maximum (RM) %) are positively associated with pleasure until the 70-80 RM% interval, a moment from which individual characteristics will reflect, albeit unclear at this point at which rate or magnitude, an inverted association with pleasure. Thus, targeting the intensity-pleasure/displeasure relation individually may be of particular relevance for the exercise domain when aiming to promote adherence.

Exercise prescription - a tripartite approach

A call for an exercise prescription aiming pleasure promotion has been proposed by several authors. This entails that current exercise prescription guidelines are heavily focused on a dose-response relation derived from an effectiveness (e.g., fitness gains) and safety of the prescription (e.g., reduced risk of injury for the general population) standpoint. Despite its relevance, this bipartite or biomedical approach (e.g., rationale for a given dose of a drug and expected outcome) tends to overlook other relevant variables needed for, for example, behavior maintenance or individual preferences. Although some flexibility of this rationale may account for personal differences, how to adequately adjust the training variables to individual characteristics is still poorly explored or even expressed.

The call for a tripartite exercise prescription reflects the bout of evidence that supports the relevance of pleasurable experiences in exercise and their impact on adherence. Thus, besides an effective and safe program, contemplating how to assess and promote exercise-related pleasurable experiences are paramount. As stated in 2011 on the ACSM position stand, affect-regulation did not behold the necessary evidence to be a primary method of exercise prescription, although affect assessment (e.g., through the feeling scale) was proposed to be relevant for exercise intensity self-regulation. A decennial look at the ACSM exercise guidelines shows, and although presenting an advancement in affect-related behavioral strategies and theories, that no clear indications on operational instruments for assessment and admeasurement of affect are presented, which depicts a barrier to an adequate advancement in this matter. This can be seen, for example, in ACSM principles for exercise prescription (Frequency, Intensity, Time, and Type; FITT). Although supporting the use of affect regulation for exercise promotion and maintenance, the FITT is not based on a previous (e.g., preexercise evaluation) or in-session affective assessment, and more importantly, does not address how to adjust exercise prescription/supervision aiming to improve the pleasure/displeasure relation.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 45 years old,
* Apparently healthy and without contraindications to exercise,
* Normal weight (BMI ≥18.5 \<29.9 Kg/m2);
* To have previous experience in a gym or health club
* To be at least 6 months without any type of regular strength, cardiovascular, or flexibility workouts (\< 5 workouts/month) in a health club or any kind of structured sports activity).

Exclusion Criteria:

Before enrollment

* High in the risk stratification for cardiovascular disease (ACSM, 2021)
* High blood pressure (≥ 130/80mmHg) in the initial preexercise evaluation

During the intervention

* Acquired injury
* The inability to perform 2 exercise sessions (48h to 96h apart) in two consecutive weeks

Primary outcomes:
measure: Post-intervention exercise attendance to the health club
timeFrame: During 8 weeks, at day 7, 14, 21, 28, 35, 42, 49, and 56
Secondary outcomes:
measure: Exercise habit measured with the Self-reported behavioral automaticity index (SRBAI)
timeFrame: 5 minutes before the first session
measure: Exercise habit measured with the Self-reported behavioral automaticity index (SRBAI)
timeFrame: 5 minutes after the last session
measure: Initial behavioral intention to continue exercising; the intention to exercise questionnaire
timeFrame: 5 minutes before the first session
measure: Final behavioral intention to continue exercising; the intention to exercise questionnaire
timeFrame: 5 minutes after the last session
measure: Motivation to exercise measured with the enjoyment/interest scale of the Intrinsic Motivation Inventory
timeFrame: 5 minutes before the first session
measure: Motivation to exercise measured with the enjoyment/interest scale of the Intrinsic Motivation Inventory
timeFrame: 5 minutes after the last session
measure: Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory
timeFrame: 5 minutes before the first session
measure: Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory
timeFrame: 5 minutes after the last session
measure: Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory
timeFrame: 5 minutes before the first session
measure: Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory
timeFrame: 5 minutes after the last session
measure: Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS)
timeFrame: 5 minutes before the first session
measure: Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS)
timeFrame: 5 minutes after the last session
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: At minute 5
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: At minute 10 of the session
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: At minute 15 of the session
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: Immediately after resistance exercise
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: Immediately after stretching exercise
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: At minute 45 of the session
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: At minute 50 of the session
measure: Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
timeFrame: At minute 55 of the session
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: At minute 5
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: At minute 10
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: At minute 15
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: Immediately after resistance exercise
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: Immediately after stretching exercise
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: At minute 45
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: At minute 50
measure: Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
timeFrame: At minute 55
measure: Initial affective attitudes related to exercise
timeFrame: 5 minutes before the session
measure: Final affective attitudes related to exercise
timeFrame: 48 hours after the end of the intervention (all sessions)
measure: Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)
timeFrame: Measured at baseline; 5 minutes before the session
measure: Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)
timeFrame: Measured at the end of the intervention (all sessions); 5 minutes after the last session
measure: Anticipated affective response to exercise
timeFrame: 5 minutes before the session
measure: Final anticipated affective response to exercise
timeFrame: 48 hours after the intervention
measure: Remembered affect to the previous exercise session
timeFrame: 5 minutes before the session
measure: Final remembered affect to the previous exercise session
timeFrame: 48 hours after the intervention
Other outcomes:
measure: Resting blood pressure (mmHg)
timeFrame: 10 minutes before the first exercise session
measure: Heart rate during exercise (bpm)
timeFrame: During all the exercise session (60 minutes); measured in the three sessions
measure: Adaption and fatigue to the workout measured with the Hooper index
timeFrame: 24 hours after the session
Locations:
city: Lisbon
country: Portugal
facility: People Family Club
Study officials:
affiliation: Grupo Lusófona
name: Diogo S. Teixeira, PhD
role: PRINCIPAL_INVESTIGATOR
References: