Feelings About Exercise

Overview

This study seeks to investigate why some individuals exercise more than others by focusing on feelings related to exercise. This two part study first examines whether regular exercisers (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout makes them feel. All participants will walk on a treadmill for 30 minutes on two separate occasions and will be asked to report on how they feel before, during, and after exercise, how they anticipate that exercise will make them feel, and how they remembered feeling during exercise. In addition, after exercise session #2, non-exercisers will be randomized to: 1) a brief intervention focused on providing general information about the physical activity guidelines, or 2) a brief intervention which provides general information about physical activity guidelines, but also focuses on affective responses to physical activity. Non-exercisers will complete an identical, third exercise session approximately 1-week following this intervention. Further, all participants will receive a 12-week, Internet-delivered weight loss program following all exercise visits and physical activity will be assessed before and after the weight loss program.

Full Title of Study: “Affective Responses to Physical Activity: A Novel Intervention Target for Increasing Physical Activity”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 12, 2019

Interventions

  • Behavioral: Affect and physical activity
    • The focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity.
  • Behavioral: Physical activity information
    • Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.

Arms, Groups and Cohorts

  • Active Comparator: Physical activity information – for non-exercisers only
    • Non-exercisers randomized to this condition will receive basic information about physical activity. This includes the national physical activity guidelines,clarification of ‘moderate-intensity’, exercise safety, and the progression of physical activity within the weight loss program.
  • Experimental: Affect and physical activity – for non-exercisers only
    • Non-exercisers randomized to this condition will receive the same basic information about physical activity as described above, but they will also receive a brief intervention focused on affective responses to exercise.
  • No Intervention: Exercisers
    • Engaging in >=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
  • No Intervention: Non-exercisers
    • Engaging in <30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week

Clinical Trial Outcome Measures

Primary Measures

  • Pre-exercise Affect (Session 1)
    • Time Frame: Prior to exercise
    • Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect
  • Mean During Exercise Affect (Session 1)
    • Time Frame: average score assessed every 5 minutes during exercise, up to 30 minutes
    • Average during exercise Feeling Scale (FS) score which was assessed every 5 minutes during exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
  • Post-exercise Affect (Session 1)
    • Time Frame: 15 minutes post-exercise
    • Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
  • Memory of During Exercise Affect (Session 1) – Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect
    • Time Frame: average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise
    • Calculated as follows: recalled during exercise affect (assessed 7 days post-exercise) minus actual during exercise affect (average of Feeling Scale scores every 5 minutes during exercise). Possible scores for both recalled affect and actual affect range from -5 to +5, where higher numbers indicate more positive affect. A negative change value indicates that participants remembered feeling less positive during exercise than they actually felt.
  • Memory of Post-exercise Affect (Session 1) – Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect
    • Time Frame: 15 minutes and 7 days post-exercise
    • Calculated as follows: recalled post-exercise affect (assessed 7 days following exercise session) minus actual post-exercise affect (Feeling Scale score assessed 15 minutes post-exercise). Possible scores for both recalled affect and actual affect range from -5 to +5, where higher numbers indicate more positive affect. A negative change value indicates that participants remembered feeling less positive post-exercise than they actually felt.
  • Anticipated During Exercise Affect (Session 2)
    • Time Frame: prior to exercise session
    • How one anticipates that they will feel during exercise session 2 (an exercise session that is identical to exercise session 1).This was assessed prior to exercise session 2 via a 100 mm visual analogue scale (range 1-100) where a higher number indicates more positive affect.

Secondary Measures

  • Pre-exercise Affect (Session 3)
    • Time Frame: Prior to exercise
    • Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect
  • Mean During Exercise Affect (Session 3)
    • Time Frame: average score assessed every 5 minutes during exercise, up to 30 minutes
    • Average during exercise Feeling Scale (FS) score which was assessed every 5 minutes during exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.
  • Post-exercise Affect (Session 3)
    • Time Frame: 15 minutes post-exercise
    • Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18-60 years – BMI between 25.0 and <40.0 kg/m2 – Either a 'Non-exerciser', defined as reporting exercising at a moderate-intensity for <30 min/week over the past 6 months and a most recent typical week or an 'exerciser', defined as exercising for ≥150 min/week over the past 6 months and a most recent typical week. Exclusion Criteria:

  • Presence of any condition that would limit one's ability to exercise (e.g., orthopedic limitations) – History of coronary artery disease (i.e., myocardial infarction or symptoms of angina), stroke, diabetes, or pulmonary disease (e.g., COPD or emphysema). – Currently taking any medication that would alter heart rate (e.g., beta blocker) – Women who are pregnant or nursing – Uncontrolled hypertension (resting blood pressure ≥140/90 mmHg) – Exercising >30 min/week but <150 min/week (i.e., neither 'non-exerciser' nor 'exerciser') – Use of medications for weight loss, or current participation in another weight loss program – Bariatric surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The Miriam Hospital
  • Collaborator
    • Brown University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jessica Unick, PhD, Principal Investigator, The Miriam Hospital
    • Kathryn Demos, PhD, Principal Investigator, The Miriam Hospital
    • David Williams, PhD, Principal Investigator, Brown University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.