Adherence to Different Exercise Interventions

Sponsor

California Polytechnic State University-San Luis Obispo (Other)

Overall Status

Recruiting

CT.gov ID

NCT06024577

Collaborator

(none)

Enrollment

Location

Arms

58.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Only 50% of sedentary adults that start an exercise training program adhere to the program after 6 months. Exercise variety may improve adherence. The goal of this study is to examine different exercise interventions that include a variety of exercise on adherence.

Condition or Disease	Intervention/Treatment	Phase
Exercise Adherence	Behavioral: Walking Behavioral: Variety Behavioral: Progressive	N/A

Detailed Description

Regular exercise, in the form of walking 150 minutes per week, is widely regarded as having many health and fitness benefits. Despite these well-known benefits, adherence to exercise interventions is extremely low. When sedentary adults start an exercise training program only 50% adhere to the program and meet the national recommendations of 150 minutes per week. A possible explanation of the low adherence is that most adults only walk for exercise, and that providing a variety of exercise may increase adherence. Preliminary observational data show that a variety of exercise may increase weekly exercise expenditure compared to other interventions. The overall objective of this study is to investigate the feasibility, adherence, and acceptability of different exercise interventions including 1) walk intervention, 2) variety intervention, and 3) progressive intervention (see below for description).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized study to three arms: 1) walk intervention, 2) variety intervention, 3) progressive interventionRandomized study to three arms: 1) walk intervention, 2) variety intervention, 3) progressive intervention

Masking:

Single (Outcomes Assessor)

Masking Description:

Research staff collecting data will be masked to intervention

Primary Purpose:

Treatment

Official Title:

Aherence to Different Exercise Interventions

Actual Study Start Date :

Aug 18, 2023

Anticipated Primary Completion Date :

Jul 1, 2027

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Walking Participants prescribed 150 minutes/week of moderate to vigorous walking.	Behavioral: Walking Prescribed 150 minutes per week of moderate to vigorous walking.
Experimental: Variety Participants prescribed 150 minutes/week of moderate to vigorous variety of exercise. Each week participants will be prescribed a single different exercise (variety) which will include cycling, walking/jogging, yoga/Pilates, and cross-training.	Behavioral: Variety Prescribed 150 minutes per week of moderate to vigorous variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training.
Experimental: Progressive Participants prescribed 150 minutes/week of moderate to vigorous exercise. The exercises include cycling, walking/jogging, yoga/Pilates, and cross-training, and each week another exercise will be added to the list of options for participants. Participants may choose from the list of exercise. They do not have to do them all, and they can do as much or little (none) of whatever they choose.	Behavioral: Progressive Prescribed 150 minutes per week of moderate to vigorous progressive variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training. Participants can choose which exercise they want to do, and can do as much or little as they want.

Arm

Intervention/Treatment

Active Comparator: Walking

Participants prescribed 150 minutes/week of moderate to vigorous walking.

Behavioral: Walking

Prescribed 150 minutes per week of moderate to vigorous walking.

Experimental: Variety

Participants prescribed 150 minutes/week of moderate to vigorous variety of exercise. Each week participants will be prescribed a single different exercise (variety) which will include cycling, walking/jogging, yoga/Pilates, and cross-training.

Behavioral: Variety

Prescribed 150 minutes per week of moderate to vigorous variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training.

Experimental: Progressive

Participants prescribed 150 minutes/week of moderate to vigorous exercise. The exercises include cycling, walking/jogging, yoga/Pilates, and cross-training, and each week another exercise will be added to the list of options for participants. Participants may choose from the list of exercise. They do not have to do them all, and they can do as much or little (none) of whatever they choose.

Behavioral: Progressive

Prescribed 150 minutes per week of moderate to vigorous progressive variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training. Participants can choose which exercise they want to do, and can do as much or little as they want.

Outcome Measures

Primary Outcome Measures

Adherence to exercise intervention [Change from baseline at 1-week, 2-weeks, 3-weeks, and 4-weeks]
Adherence is assessed as meeting or exceeding 150 minutes per week of moderate to vigorous exercise

Secondary Outcome Measures

Acceptability of intervention [Acceptability at 4-weeks]
Participants will complete a survey on acceptability at the end of the exercise intervention
Body Weight [Change in body weight from baseline to 4-weeks]
Body weight will be measured at baseline and 4-weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-40 years old
Sedentary (<1 hour per week of exercise)
BMI 18.5 to 40 kg/m2

Exclusion Criteria:

Adults with diagnosed cardiovascular, diabetes, renal, or any other metabolic disease determined by Health and Fitness History questionnaire.
Any other disability, ailment, or physical characteristics that may hinder the ability to participate in regular exercise determined by Health and Fitness History questionnaire.
Participating in other studies that would interfere with their ability to safely complete the exercise protocols.
Pregnant or trying to become pregnant, and peri-menopausal or post-menopausal women.
History of smoking within the last 6 months
Any other vulnerable population (children <18, pregnant women, prisoners, etc.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Polytechnic State University	San Luis Obispo	California	United States	93407

Sponsors and Collaborators

California Polytechnic State University-San Luis Obispo

Investigators

Principal Investigator: Todd Hagobian, California Polytechnic State University-San Luis Obispo

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Todd Hagobian, Chair and Professor, California Polytechnic State University-San Luis Obispo

ClinicalTrials.gov Identifier:

NCT06024577

Other Study ID Numbers:

2023-152

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 6, 2023