NCT05416593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

May 2, 2022

Last Update Submit

November 24, 2022

Conditions

Keywords

AffectAffective responseExerciseAffective determinantsCircumplex model

Outcome Measures

Primary Outcomes (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

    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)

    5 minutes before the first session

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

    5 minutes after the last session

  • Initial behavioral intention to continue exercising; the intention to exercise questionnaire

    5 minutes before the first session

  • Final behavioral intention to continue exercising; the intention to exercise questionnaire

    5 minutes after the last session

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

    5 minutes before the first session

  • +31 more secondary outcomes

Other Outcomes (3)

  • Resting blood pressure (mmHg)

    10 minutes before the first exercise session

  • Heart rate during exercise (bpm)

    During all the exercise session (60 minutes); measured in the three sessions

  • Adaption and fatigue to the workout measured with the Hooper index

    24 hours after the session

Study Arms (2)

General exercise prescription (FITT)

PLACEBO COMPARATOR

Exercise group; control; general exercise prescription

Behavioral: General exercise prescription (FITT)

Affective regulation (AFFECT)

EXPERIMENTAL

Exercise group; experimental; general exercise prescription plus affective response and preferences regulation

Behavioral: Affective regulation (AFFECT)

Interventions

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.

General exercise prescription (FITT)

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).

Affective regulation (AFFECT)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People Family Club

Lisbon, 2735-534, Portugal

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Coe Comfort

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Diogo S. Teixeira, PhD

    Grupo Lusófona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 2, 2022

First Posted

June 13, 2022

Study Start

August 1, 2022

Primary Completion

November 24, 2022

Study Completion

November 24, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations