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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| General exercise prescription (FITT) | Placebo comparator | Exercise group; control; general exercise prescription Receives: Behavioral: General exercise prescription (FITT) |
| Affective regulation (AFFECT) | Experimental | Exercise 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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.
- First posted13 Jun 2022
- Study start1 Aug 2022
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Grupo Lusófona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diogo Teixeira, Grupo Lusófona
- Investigators
- Diogo S. Teixeira, PhD, Principal investigator, Grupo Lusófona
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 39103923Teixeira 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Motivational Impact of Individualized Pleasure-Oriented Exercise Sessions in a Health Club Setting: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05416593
- Acronym / sponsor ID
- GrupoLusofona_RCT_AFFECT
- Conditions
- Affect
- Keywords
- Affect, Affective response, Exercise, Affective determinants, Circumplex model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Grupo LusófonaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General exercise prescription (FITT) | Placebo comparator | Behavioral: General exercise prescription (FITT)Exercise group; control; general exercise prescription |
| Affective regulation (AFFECT) | Experimental | Behavioral: Affective regulation (AFFECT)Exercise group; experimental; general exercise prescription plus affective response and preferences regulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General exercise prescription (FITT)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. | Behavioural | General exercise prescription (FITT) |
| Affective regulation (AFFECT)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). | Behavioural | Affective regulation (AFFECT) |
Primary outcome
Post-intervention exercise attendance to the health club
Time frame: During 8 weeks, at day 7, 14, 21, 28, 35, 42, 49, and 56
Post-intervention weekly exercise frequency, objectively measured by the accesses via the turnstile in the health clubs
36 secondary outcomes
Exercise habit measured with the Self-reported behavioral automaticity index (SRBAI)
Time frame: 5 minutes before the first session
Exercise habit measured with the Self-reported behavioral automaticity index (SRBAI)
Time frame: 5 minutes after the last session
Initial behavioral intention to continue exercising; the intention to exercise questionnaire
Time frame: 5 minutes before the first session
Final behavioral intention to continue exercising; the intention to exercise questionnaire
Time frame: 5 minutes after the last session
Motivation to exercise measured with the enjoyment/interest scale of the Intrinsic Motivation Inventory
Time frame: 5 minutes before the first session
Motivation to exercise measured with the enjoyment/interest scale of the Intrinsic Motivation Inventory
Time frame: 5 minutes after the last session
Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory
Time frame: 5 minutes before the first session
Autonomy in exercise practice measured with the perceived choice scale of the Intrinsic Motivation Inventory
Time frame: 5 minutes after the last session
Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory
Time frame: 5 minutes before the first session
Competence in exercise practice measured with the competence scale of the Intrinsic Motivation Inventory
Time frame: 5 minutes after the last session
Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS)
Time frame: 5 minutes before the first session
Subjective vitality in exercise measured with the subjective vitality in exercise scale (SVS)
Time frame: 5 minutes after the last session
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: At minute 5
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: At minute 10 of the session
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: At minute 15 of the session
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: Immediately after resistance exercise
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: Immediately after stretching exercise
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: At minute 45 of the session
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: At minute 50 of the session
Feelings in exercise; assessed with the Feeling Scale; score ranges between -5 and +5; higher values represent a better outcome
Time frame: At minute 55 of the session
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: At minute 5
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: At minute 10
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: At minute 15
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: Immediately after resistance exercise
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: Immediately after stretching exercise
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: At minute 45
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: At minute 50
Arousal/Activation in exercise; assessed with the Felt Arousal Scale; score ranges between 1 and 6; higher values represent a better outcome
Time frame: At minute 55
Initial affective attitudes related to exercise
Time frame: 5 minutes before the session
Final affective attitudes related to exercise
Time frame: 48 hours after the end of the intervention (all sessions)
Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)
Time frame: Measured at baseline; 5 minutes before the session
Exercise enjoyment measured with the the Physical Activity Enjoyment Scale (PACES)
Time frame: Measured at the end of the intervention (all sessions); 5 minutes after the last session
Anticipated affective response to exercise
Time frame: 5 minutes before the session
Final anticipated affective response to exercise
Time frame: 48 hours after the intervention
Remembered affect to the previous exercise session
Time frame: 5 minutes before the session
Final remembered affect to the previous exercise session
Time frame: 48 hours after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 39103923Teixeira 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.
- Derived from this study: PubMed 37665877Teixeira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diogo S. Teixeira, PhD principal investigator
Grupo Lusófona
1 site in 1 country: see every site and its status.
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.