Trial Outcomes & Findings for Feelings About Exercise (NCT NCT03598647)

Results Overview

Measured using Feeling Scale (FS) prior to exercise bout. Scores range from -5 to +5 with higher values indicating more positive affect

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Prior to exercise

Results posted on

2021-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Exercisers Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Physical Activity Information After the completion of exercise sessions 1 and 2 (which were necessary for the aims comparing exercisers vs. non-exercisers), non-exercisers randomized to this condition received basic information about physical activity, including the national physical activity guidelines, clarification of 'moderate-intensity', exercise safety, and the progression of physical activity within the weight loss program.	Affect and Physical Activity After the completion of exercise sessions 1 and 2 (which were necessary for the aims comparing exercisers vs. non-exercisers), non-exercisers randomized to this condition received the same basic information about physical activity as the 'physical activity information' group but they also received a brief intervention focused on affective responses to exercise. The focus of this intervention was to help the participant to become more aware of their positive feelings and experiences related to exercise. They learned about typical affective responses to exercise, viewed their own affective responses to exercise, and were taught cognitive strategies for altering affective responses to exercise.
Exercisers vs. Non-exercisers STARTED	30	30	0	0
Exercisers vs. Non-exercisers COMPLETED	29	30	0	0
Exercisers vs. Non-exercisers NOT COMPLETED	1	0	0	0
Interventions for Non-exercisers STARTED	0	0	14	16
Interventions for Non-exercisers COMPLETED	0	0	14	16
Interventions for Non-exercisers NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feelings About Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Total n=59 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 8.9 • n=93 Participants	45.0 years STANDARD_DEVIATION 11.3 • n=4 Participants	47.1 years STANDARD_DEVIATION 10.3 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	25 Participants n=4 Participants	47 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants	28 Participants n=4 Participants	56 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	29 Participants n=93 Participants	30 Participants n=4 Participants	59 Participants n=27 Participants
Self-reported exercise minutes (min/week) over past 6 months	285.9 min/week STANDARD_DEVIATION 148.8 • n=93 Participants	14.0 min/week STANDARD_DEVIATION 15.2 • n=4 Participants	147.6 min/week STANDARD_DEVIATION 172.0 • n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Pre-exercise Affect (Session 1)	3.97 units on a scale Standard Deviation 1.40	2.70 units on a scale Standard Deviation 2.15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Mean During Exercise Affect (Session 1)	3.53 units on a scale Standard Deviation 1.64	2.71 units on a scale Standard Deviation 1.54

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Post-exercise Affect (Session 1)	4.03 units on a scale Standard Deviation 1.32	3.80 units on a scale Standard Deviation 1.27

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Memory of During Exercise Affect (Session 1) - Calculated as the Difference Between Recalled During Exercise Affect and Actual During Exercise Affect	-.77 units on a scale Standard Deviation 1.22	-.80 units on a scale Standard Deviation 1.23

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Memory of Post-exercise Affect (Session 1) - Calculated as the Difference Between Recalled Post-exercise Affect and Actual Post-exercise Affect	-1.07 units on a scale Standard Deviation 1.21	-0.76 units on a scale Standard Deviation 1.81

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=29 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=30 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Anticipated During Exercise Affect (Session 2)	71.3 units on a scale Standard Deviation 18.7	54.1 units on a scale Standard Deviation 21.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Exercisers n=14 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=16 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Pre-exercise Affect (Session 3)	2.11 units on a scale Standard Deviation 1.70	2.94 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=14 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=16 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Mean During Exercise Affect (Session 3)	3.14 units on a scale Standard Deviation 1.69	3.14 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exercisers n=14 Participants Engaging in \>=150 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week	Non-exercisers n=16 Participants Engaging in \<30 min/week of moderate-intensity exercise over the past 6 months and a most recent typical week
Post-exercise Affect (Session 3)	3.71 units on a scale Standard Deviation 1.27	3.94 units on a scale Standard Deviation 0.85

Adverse Events

Exercisers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-exercisers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physical Activity Information

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Affect and Physical Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Unick, PD (Principal Investigator)

The Miriam Hospital

Phone: 401-793-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place