Clinical trial NCT04207567: Minute Calisthenics: A Daily, Habit-Based, Bodyweight Resistance-Training Program
Official title: Minute Calisthenics: A Daily, Habit-Based, Bodyweight Resistance-Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
Collaborators: name: Auburn University
First posted: 2019-12-23
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized (1:1) to an intervention or waitlist control group. The intervention group will perform one set of the bodyweight exercises (i.e., push-ups, angled-rows, bodyweight squats), with training and coaching, unsupervised every weekday for 12 weeks. The waitlist control group will refrain from resistance training for the initial 12.

After a 12-week follow-up assessment, the intervention group will continue the RT program for an additional 12 weeks, and the waitlist control group will initiate the RT program and continue for 12 weeks. A 24-week follow-up assessment will then be conducted.
Primary purpose: OTHER

Brief 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.

Detailed 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

Eligibility criteria: 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).

Primary outcomes:
measure: Physical strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical strength
timeFrame: Up to 24 weeks
measure: Blood pressure
timeFrame: Baseline, 12-week, and 24-week follow-up
measure: Lipid profile
timeFrame: Baseline, 12-week, and 24-week follow-up
measure: Hemoglobin A1c
timeFrame: Baseline, 12-week, and 24-week follow-up
measure: Habit strength
timeFrame: 12 weeks
measure: Adherence to protocol
timeFrame: 12 weeks
measure: Satisfaction with program
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Auburn
country: United States
facility: Edward Via College of Osteopathic Medicine-Auburn Campus
state: Alabama
Study officials:
affiliation: Edward Via College of Osteopathic Medicine (VCOM-Auburn)
name: Joshua C Hollingsworth, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: National Center for Health Statistics (US). Health, United States, 2017: With Special Feature on Mortality [Internet]. Hyattsville (MD): National Center for Health Statistics (US); 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532685/
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.
citation: Hollingsworth JC, Young KC, Abdullah SF, Wadsworth DD, Abukhader A, Elfenbein B, Holley Z. Protocol for Minute Calisthenics: a randomized controlled study of a daily, habit-based, bodyweight resistance training program. BMC Public Health. 2020 Aug 15;20(1):1242. doi: 10.1186/s12889-020-09355-4.