Physical ActivityNCT02507869
A Trial of an Affect-Guided Physical Activity Prescription
A study testing Positive affective response and Moderate-intensity heart rate in people with Physical Activity, run by Southern Methodist University.
Trial summary
Despite awareness of the benefits of engaging in regular physical activity, at least 50% of adults in the US do not meet recommended guidelines for physical activity. One potential explanation for this lack of regular physical activity is that people often experience exercise as affectively unpleasant. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Positive affective response and Moderate-intensity heart rate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physically underactive individuals (< 60 minutes of physical activity/week).
Who cannot join
- Presence of cardiovascular disease, pulmonary disease, or hypertension.
About this study
Official title: A Pilot Randomized Controlled Trial of an Affect-Guided Physical Activity
Despite awareness of the benefits of engaging in regular physical activity, at least 50% of adults in the US do not meet recommended guidelines for physical activity. One potential explanation for this lack of regular physical activity is that people often experience exercise as affectively unpleasant. Evidence suggests that the more positively people experience exercise (i.e., the better they feel while exercising), the more likely they are to engage in regular physical activity. This may be especially true for people in poor cardiorespiratory condition. In this randomized trial, investigators compared the effects of an affect-guided exercise prescription (intervention) to a heart rate-guided exercise prescription (control) on change in physical activity minutes among previously underactive adults. Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Read the detailed description
Regular physical activity has many benefits for overall health and well-being, and current public health guidelines recommend at least 150 minutes per week of moderate-to-vigorous intensity activity to attain these benefits. Despite the many benefits of regular activity, the majority of adults in the US fail to meet recommendations for regular physical activity. One potential explanation for suboptimal levels of physical activity is that exercise is often experienced as affectively unpleasant. Recent work has demonstrated that the more positive people feel during exercise, the more likely they are to engage in regular physical activity. Affective response to exercise is modulated by the intensity of the activity: at a vigorous intensity, affective response is almost uniformly negative and unpleasant, whereas at a moderate intensity, there is more inter-individual variability in affective response. Whether the intensity of the exercise is self-selected or imposed also influences the affective response to exercise, with self-selected intensities being experienced as more pleasant. Current recommendations for engaging in physical activity focus on the type of training intensities most likely to result in a negative affective response. The purpose of this pilot trial was to test the effects of an exercise prescription focused on the maintenance of positive affect during exercise. Investigators randomized participants to one of two exercise prescription conditions: (1) an affect-guided prescription focused on maintaining a positive affective response (intervention), and (2) a heart rate-guided prescription focused on maintaining a moderate intensity (control). Investigators tested the effects of these two exercise prescriptions on changes in subsequent physical activity after one week and one month among a sample of underactive adults. Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
- Conditions
- Physical Activity
- Being tested
- Positive affective response, Moderate-intensity heart rate
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive affective responseBehavioural
Participants adjust the intensity of their exercise to maintain a pleasant affective response.
Moderate-intensity heart rateBehavioural
Participants adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax).
| Study group | Role | What they receive |
|---|---|---|
| Affect-Guided Prescription | Experimental | Intervention: Participants in the affect-guided condition are instructed to exercise while monitoring how they feel, and to adjust the intensity of their exercise to maintain a pleasant affective response. Receives: Behavioral: Positive affective response |
| Heart Rate-Guided Prescription | Active comparator | Intervention: Participants in the heart rate-guided condition are instructed to exercise while monitoring their heart rate, and to adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax). Receives: Behavioral: Moderate-intensity heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity minutes measured by the 7-day PAR
Measured: One week
Change in physical activity minutes measured by the 7-day PAR
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Austin Baldwin, Southern Methodist University
- Investigators
- Austin Baldwin, Ph.D., Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507869
- Sponsor's protocol ID
- 2012-098-SMIJ
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ekkekakis P, Lind E. Exercise does not feel the same when you are overweight: the impact of self-selected and imposed intensity on affect and exertion. Int J Obes (Lond). 2006 Apr;30(4):652-60. doi: 10.1038/sj.ijo.0803052.
PubMed 16130028Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165/11590680-000000000-00000.
PubMed 21780850Ekkekakis P, Lind E, Vazou S. Affective responses to increasing levels of exercise intensity in normal-weight, overweight, and obese middle-aged women. Obesity (Silver Spring). 2010 Jan;18(1):79-85. doi: 10.1038/oby.2009.204. Epub 2009 Jun 25.
PubMed 19556979Parfitt G, Alrumh A, Rowlands AV. Affect-regulated exercise intensity: does training at an intensity that feels 'good' improve physical health? J Sci Med Sport. 2012 Nov;15(6):548-53. doi: 10.1016/j.jsams.2012.01.005. Epub 2012 May 31.
PubMed 22658587Williams DM, Dunsiger S, Jennings EG, Marcus BH. Does affective valence during and immediately following a 10-min walk predict concurrent and future physical activity? Ann Behav Med. 2012 Aug;44(1):43-51. doi: 10.1007/s12160-012-9362-9.
PubMed 22532005Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7.
PubMed 25223963
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of an Affect-Guided Physical Activity
- ClinicalTrials.gov ID
- NCT02507869
- Acronym / sponsor ID
- 2012-098-SMIJ
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Jul 2015 (estimated)
- 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.
Despite awareness of the benefits of engaging in regular physical activity, at least 50% of adults in the US do not meet recommended guidelines for physical activity. One potential explanation for this lack of regular physical activity is that people often experience exercise as affectively unpleasant. Evidence suggests that the more positively people experience exercise (i.e., the better they feel while exercising), the more likely they are to engage in regular physical activity. This may be especially true for people in poor cardiorespiratory condition. In this randomized trial, investigators compared the effects of an affect-guided exercise prescription (intervention) to a heart rate-guided exercise prescription (control) on change in physical activity minutes among previously underactive adults. Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Detailed description
Regular physical activity has many benefits for overall health and well-being, and current public health guidelines recommend at least 150 minutes per week of moderate-to-vigorous intensity activity to attain these benefits. Despite the many benefits of regular activity, the majority of adults in the US fail to meet recommendations for regular physical activity. One potential explanation for suboptimal levels of physical activity is that exercise is often experienced as affectively unpleasant. Recent work has demonstrated that the more positive people feel during exercise, the more likely they are to engage in regular physical activity. Affective response to exercise is modulated by the intensity of the activity: at a vigorous intensity, affective response is almost uniformly negative and unpleasant, whereas at a moderate intensity, there is more inter-individual variability in affective response. Whether the intensity of the exercise is self-selected or imposed also influences the affective response to exercise, with self-selected intensities being experienced as more pleasant. Current recommendations for engaging in physical activity focus on the type of training intensities most likely to result in a negative affective response. The purpose of this pilot trial was to test the effects of an exercise prescription focused on the maintenance of positive affect during exercise. Investigators randomized participants to one of two exercise prescription conditions: (1) an affect-guided prescription focused on maintaining a positive affective response (intervention), and (2) a heart rate-guided prescription focused on maintaining a moderate intensity (control). Investigators tested the effects of these two exercise prescriptions on changes in subsequent physical activity after one week and one month among a sample of underactive adults. Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affect-Guided Prescription | Experimental | Behavioral: Positive affective responseIntervention: Participants in the affect-guided condition are instructed to exercise while monitoring how they feel, and to adjust the intensity of their exercise to maintain a pleasant affective response. |
| Heart Rate-Guided Prescription | Active comparator | Behavioral: Moderate-intensity heart rateIntervention: Participants in the heart rate-guided condition are instructed to exercise while monitoring their heart rate, and to adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physically underactive individuals (< 60 minutes of physical activity/week).
Key exclusion criteria (1 listed)
- Presence of cardiovascular disease, pulmonary disease, or hypertension.
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 |
|---|---|---|
| Positive affective responseParticipants adjust the intensity of their exercise to maintain a pleasant affective response. | Behavioural | Affect-Guided Prescription |
| Moderate-intensity heart rateParticipants adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax). | Behavioural | Heart Rate-Guided Prescription |
Primary outcome
Change in physical activity minutes measured by the 7-day PAR
Time frame: One week
Change in physical activity minutes measured by the 7-day PAR
Time frame: One month
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 24 Jul 2015.
- Background: PubMed 16130028Ekkekakis P, Lind E. Exercise does not feel the same when you are overweight: the impact of self-selected and imposed intensity on affect and exertion. Int J Obes (Lond). 2006 Apr;30(4):652-60. doi: 10.1038/sj.ijo.0803052.
- Background: PubMed 21780850Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165/11590680-000000000-00000.
- Background: PubMed 19556979Ekkekakis P, Lind E, Vazou S. Affective responses to increasing levels of exercise intensity in normal-weight, overweight, and obese middle-aged women. Obesity (Silver Spring). 2010 Jan;18(1):79-85. doi: 10.1038/oby.2009.204. Epub 2009 Jun 25.
- Background: PubMed 22658587Parfitt G, Alrumh A, Rowlands AV. Affect-regulated exercise intensity: does training at an intensity that feels 'good' improve physical health? J Sci Med Sport. 2012 Nov;15(6):548-53. doi: 10.1016/j.jsams.2012.01.005. Epub 2012 May 31.
- Background: PubMed 22532005Williams DM, Dunsiger S, Jennings EG, Marcus BH. Does affective valence during and immediately following a 10-min walk predict concurrent and future physical activity? Ann Behav Med. 2012 Aug;44(1):43-51. doi: 10.1007/s12160-012-9362-9.
- Background: PubMed 25223963Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7.
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
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.
Austin Baldwin, Ph.D. principal investigator
Southern Methodist University
Questions about this trial
What is this clinical trial studying?
A study testing Positive affective response and Moderate-intensity heart rate in people with Physical Activity, run by Southern Methodist University.
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 1 inclusion and 1 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in physical activity minutes measured by the 7-day PAR (time frame: One week). The study lists 2 primary outcomes in all. 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 NCT02507869, which also lists 6 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 24 Jul 2015.