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AffectNCT05416593

Exploring the Impact of Individualized Pleasure-Oriented Exercise Sessions in a Health Club Setting

A study testing General exercise prescription (FITT) and Affective regulation (AFFECT) in people with Affect, run by Grupo Lusófona at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Affect
What is being tested?
General exercise prescription (FITT) and Affective regulation (AFFECT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 sitePortugal
Study dates
1 Aug 2022to 24 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • People Family Club

    Lisbon, 2735-534

Other trials in Portugal

About this study

Official title: Exploring the Motivational Impact of Individualized Pleasure-Oriented Exercise Sessions in a Health Club Setting: Protocol for a Randomized Controlled Trial

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.

Read the 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.

Conditions
Affect
Being tested
General exercise prescription (FITT), Affective regulation (AFFECT)
Keywords
Affect, Affective response, Exercise, Affective determinants, Circumplex model
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General exercise prescription (FITT)Behavioural

    The (1) control group (FITT) will receive a preexercise evaluation and 3 individualized training sessions based on the ACSM and FITT principles (ACSM, 2021). These are the procedures commonly used for apparently healthy individuals that start to exercise in health clubs.

  • Affective regulation (AFFECT)Behavioural

    As for the (2) experimental group (AFFECT), the focus will be given to exercise intensity assessment and manipulation. The same preexercise evaluation, number of individualized sessions, and methodological approach (i.e., FITT) will be made. However, individual preferences and experiences regarding exercise intensity will be assessed in the preexercise evaluation. These will be used to select the exercise sessions' initial intensity. Moreover, intensity self-selection guidance and affective response assessments will be made throughout the session for continuous intensity adjustments (aiming for pleasurable feelings).

Study groups in NCT05416593
Study groupRoleWhat they receive
General exercise prescription (FITT)Placebo comparatorExercise group; control; general exercise prescription
Receives: Behavioral: General exercise prescription (FITT)
Affective regulation (AFFECT)ExperimentalExercise group; experimental; general exercise prescription plus affective response and preferences regulation
Receives: Behavioral: Affective regulation (AFFECT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-intervention exercise attendance to the health club

    Post-intervention weekly exercise frequency, objectively measured by the accesses via the turnstile in the health clubs

    Measured: During 8 weeks, at day 7, 14, 21, 28, 35, 42, 49, and 56

Secondary outcomes (36)
  1. Exercise habit measured with the Self-reported behavioral automaticity index (SRBAI)

    Automaticity for exercise practice measured with the Self-reported behavioral automaticity index (SRBAI)

    Measured: 5 minutes before the first session

  2. Exercise habit measured with the Self-reported behavioral automaticity index (SRBAI)

    Automaticity for exercise practice measured with the Self-reported behavioral automaticity index (SRBAI)

    Measured: 5 minutes after the last session

  3. Initial behavioral intention to continue exercising; the intention to exercise questionnaire

    Behavioral intention as defined by the theory of planned behavior with the intention to exercise questionnaire

    Measured: 5 minutes before the first session

  4. Final behavioral intention to continue exercising; the intention to exercise questionnaire

    Behavioral intention as defined by the theory of planned behavior with the intention to exercise questionnaire

    Measured: 5 minutes after the last session

  5. Motivation to exercise measured with the enjoyment/interest scale of the Intrinsic Motivation Inventory

    Intrinsic motivation measured with the enjoyment/interest scale Intrinsic Motivation Inventory

    Measured: 5 minutes before the first session

  6. Motivation to exercise measured with the enjoyment/interest scale of the Intrinsic Motivation Inventory

    Intrinsic motivation measured with the enjoyment/interest scale Intrinsic Motivation Inventory

    Measured: 5 minutes after the last session

  7. Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory

    Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory

    Measured: 5 minutes before the first session

  8. Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory

    Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory

    Measured: 5 minutes after the last session

  9. Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory

    Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory

    Measured: 5 minutes before the first session

  10. Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory

    Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory

    Measured: 5 minutes after the last session

  11. Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS)

    Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS) as defined by the self-determination theory

    Measured: 5 minutes before the first session

  12. Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS)

    Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS) as defined by the self-determination theory

    Measured: 5 minutes after the last session

  13. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: At minute 5

  14. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: At minute 10 of the session

  15. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: At minute 15 of the session

  16. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: Immediately after resistance exercise

  17. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: Immediately after stretching exercise

  18. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: At minute 45 of the session

  19. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: At minute 50 of the session

  20. Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome

    Measured: At minute 55 of the session

  21. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: At minute 5

  22. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: At minute 10

  23. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: At minute 15

  24. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: Immediately after resistance exercise

  25. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: Immediately after stretching exercise

  26. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: At minute 45

  27. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: At minute 50

  28. Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome

    Measured: At minute 55

  29. Initial affective attitudes related to exercise

    Individual affective attitudes for exercise measured with the Exercise and Me Questionnaire (AFFEXX)

    Measured: 5 minutes before the session

  30. Final affective attitudes related to exercise

    Individual affective attitudes for exercise measured with the Exercise and Me Questionnaire (AFFEXX)

    Measured: 48 hours after the end of the intervention (all sessions)

  31. Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)

    Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)

    Measured: Measured at baseline; 5 minutes before the session

  32. Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)

    Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)

    Measured: Measured at the end of the intervention (all sessions); 5 minutes after the last session

  33. Anticipated affective response to exercise

    Anticipated affective response to a future exercise session measured with the Empirical Valence Scale

    Measured: 5 minutes before the session

  34. Final anticipated affective response to exercise

    Anticipated affective response to a future exercise session measured with the Empirical Valence Scale

    Measured: 48 hours after the intervention

  35. Remembered affect to the previous exercise session

    Remembered affect of previous exercise session measured with the Visual Analog Scale

    Measured: 5 minutes before the session

  36. Final remembered affect to the previous exercise session

    Remembered affect of previous exercise session measured with the Visual Analog Scale

    Measured: 48 hours after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start1 Aug 2022
  3. Primary completion24 Nov 2022
  4. Study completion24 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416593
Sponsor's protocol ID
GrupoLusofona_RCT_AFFECT
Status last verified
Nov 2022
First submitted
2 May 2022
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teixeira DS, Bastos V, Andrade AJ, Palmeira AL, Ekkekakis P. Individualized pleasure-oriented exercise sessions, exercise frequency, and affective outcomes: a pragmatic randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Aug 5;21(1):85. doi: 10.1186/s12966-024-01636-0.

    PubMed 39103923
  • Teixeira DS, Ekkekakis P, Andrade AJ, Bastos V, Palmeira AL. Exploring the impact of individualized pleasure-oriented exercise sessions in a health club setting: Protocol for a randomized controlled trial. Psychol Sport Exerc. 2023 Jul;67:102424. doi: 10.1016/j.psychsport.2023.102424. Epub 2023 Mar 15.

    PubMed 37665877

Questions about this trial

What is this clinical trial studying?

A study testing General exercise prescription (FITT) and Affective regulation (AFFECT) in people with Affect, run by Grupo Lusófona at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-intervention exercise attendance to the health club (time frame: During 8 weeks, at day 7, 14, 21, 28, 35, 42, 49, and 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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