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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04207567
Other study ID # 2019-037
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2019
Est. completion date January 4, 2021

Study information

Verified date April 2021
Source Edward Via Virginia College of Osteopathic Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As the primary objective, this study will evaluate the effectiveness, in terms of changes in physical strength, of a resistance training (RT) program consisting of brief bodyweight exercises (<5 min/day) performed unsupervised every weekday for 12 weeks. Blood pressure, lipid profile, hemoglobin A1ca, habit strength and satisfaction with the program will also be assessed. Office workers and osteopathic medical students will serve as participants.They will be randomized (1:1) to the intervention group or to a waitlist control group that will refrain from RT for the initial 12 weeks. After the 12-week follow-up assessment, the intervention group will continue the program and the waitlist control group will start the program for 12 weeks, followed by a 24-week follow-up assessment.


Description:

Regular resistance training (RT) provides significant health benefits. However, roughly 3 out of 4 US adults do not meet current US Physical Activity Guidelines regarding RT. Studies are needed that assess the effectiveness and feasibility of RT programs that are time-efficient and simple to perform. This will be a randomized controlled study of a habit-based RT program consisting of one set each of push-ups, angled-rows, and bodyweight squats performed every weekday for 12 weeks. Forty to 60 office workers and osteopathic medical students, who currently do not engage in RT, will be recruited, assessed, and randomized (1:1) to an intervention group, which will perform the exercises as just described, or a waitlist control group, which will refrain from RT for 12 weeks. To promote consistent exercise performance, the intervention group will be trained in the Tiny Habits® Method (a systematic approach to adding new behaviors in one's daily routine) and receive digital coaching for the duration of the study. After the 12-week follow-up assessment, the intervention group will continue the program for an additional 12 weeks, and the waitlist control group will start the program and continue for 12 weeks, including Tiny Habits training and digital coaching. A 24-week follow-up assessment will then be conducted. The primary outcome of interest is the change from baseline to 12-weeks in physical strength from, as measured by the maximum number of composite repetitions (i.e., push-ups + angled-rows + bodyweight squats) performed under a standardized protocol. Secondary outcomes of interest include adherence to and satisfaction with the program, and change from baseline to 12- and 24-week follow-up in composite repetitions, habit strength, blood pressure, lipid panel, hemoglobin A1c, body mass index, anthropometry, body composition, and mid-thigh muscle thickness


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date January 4, 2021
Est. primary completion date September 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Office worker or osteopathic medical student at the local college/university - Demonstrate ability to properly perform 1 repetition of each exercise (push-ups, angled-rows, bodyweight squats). - Indicate having motivation and confidence in ability to perform exercises on weekdays. - Low adverse event risk while participating, as assessed via the Physical Activity Readiness-Questionnaire (PAR-Q) - Must be able to identify a suitable location (either at home, school, or office) to set up the suspension system needed to perform the angled-row exercise. Exclusion Criteria: - Pregnant - Participation in structured resistance training for =2 days/week, on average, during the past year. - Implanted medical device (e.g., pacemaker, defibrillator).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bodyweight exercises (push-ups, angled-rows, bodyweight squats) on weekdays
Participants will be instructed to perform one set each of push-ups, angled-rows, and bodyweight squats every weekday. They will be given the equipment and training necessary to properly perform the exercises. They will also be trained in the Tiny Habits® Method and receive digital coaching.

Locations

Country Name City State
United States Auburn University Auburn Alabama
United States Edward Via College of Osteopathic Medicine-Auburn Campus Auburn Alabama

Sponsors (2)

Lead Sponsor Collaborator
Edward Via Virginia College of Osteopathic Medicine Auburn University

Country where clinical trial is conducted

United States, 

References & Publications (3)

National Center for Health Statistics (US). Health, United States, 2017: With Special Feature on Mortality. Hyattsville (MD): National Center for Health Statistics (US); 2019.

Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854. — View Citation

Westcott WL. Resistance training is medicine: effects of strength training on health. Curr Sports Med Rep. 2012 Jul-Aug;11(4):209-16. doi: 10.1249/JSR.0b013e31825dabb8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physical strength As the primary outcome, the change in physical strength in the intervention group vs. the control group from baseline to 12-week follow-up will be determined by assessing the maximum number of composite repetitions (i.e., push-ups + angled rows + bodyweight squats) that the participant is able to perform under a standardized protocol. 12 weeks
Secondary Physical strength The change in physical strength baseline to 24-week follow-up, in the intervention group, and from 12-week follow-up to 24-week follow-up, in the waitlist control group, will be determined by assessing the maximum number of composite repetitions (i.e., push-ups + angled rows + bodyweight squats) that the participant is able to perform under a standardized protocol at those timepoints. Up to 24 weeks
Secondary Blood pressure Measure at baseline, 12-week, and 24-week follow-up following guideline recommendations and using a calibrated automated blood pressure cuff. Baseline, 12-week, and 24-week follow-up
Secondary Lipid profile Total cholesterol, (calculated) LDL, HDL, and triglycerides measured at baseline, 12-week, and 24-week follow-up using the CardioChek Plus Analyzer. Baseline, 12-week, and 24-week follow-up
Secondary Hemoglobin A1c Measured at baseline, 12-week, and 24-week follow-up using the PTS Diagnostics A1CNow+ System. Baseline, 12-week, and 24-week follow-up
Secondary Habit strength Each week during the initial 12-weeks of their intervention phase, participants will complete a survey that, among other things, assesses change in habit strength regarding exercise performance (push-ups, angled-rows, bodyweight squats), via the validated Self-Report Behavioral Automaticity Index (SRBAI). 12 weeks
Secondary Adherence to protocol Each week during the initial 12-weeks of their intervention phase, participants will complete a survey that, among other things, will assess their (self-reported) adherence to the resistance-training protocol. 12 weeks
Secondary Satisfaction with program Each week during the initial 12-weeks of their intervention phase, participants will complete a survey that, among other things, is meant to assess their level of satisfaction with the program. 12 weeks
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