Feelings About Exercise

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598647
• Other study ID #: 1179772
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: October 22, 2019

Study information

• Verified date: November 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 22, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United States	Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University, National Institute of General Medical Sciences (NIGMS): U54GM115677

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-exercise Affect (Session 1)	Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect	Prior to exercise
Primary	Mean During Exercise Affect (Session 1)	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.	average score assessed every 5 minutes during exercise, up to 30 minutes
Primary	Post-exercise Affect (Session 1)	Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.	15 minutes post-exercise
Primary	Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect	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.	average score assessed every 5 minutes during exercise, up to 30 minutes, and 7 days post-exercise
Primary	Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect	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.	15 minutes and 7 days post-exercise
Primary	Anticipated During Exercise Affect (Session 2)	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.	prior to exercise session
Secondary	Pre-exercise Affect (Session 3)	Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect	Prior to exercise
Secondary	Mean During Exercise Affect (Session 3)	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.	average score assessed every 5 minutes during exercise, up to 30 minutes
Secondary	Post-exercise Affect (Session 3)	Feeling Scale (FS) score 15 minutes post-exercise. Feeling Scale scores range from -5 to +5 with higher values indicating more positive affect.	15 minutes post-exercise