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Completed

NCT Number: NCT03598647

Feelings About Exercise

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Affect and physical activity

Behavioral

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.

Physical activity information

Behavioral

Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Brown University
  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Affective Responses to Physical Activity: A Novel Intervention Target for Increasing Physical Activity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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