NCT04207567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

December 16, 2019

Last Update Submit

April 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Physical strength

    Up to 24 weeks

  • Blood pressure

    Baseline, 12-week, and 24-week follow-up

  • Lipid profile

    Baseline, 12-week, and 24-week follow-up

  • Hemoglobin A1c

    Baseline, 12-week, and 24-week follow-up

  • Habit strength

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants in this arm will be instructed to perform one set each of push-ups, angled-rows and bodyweight squats every weekday without supervision for a total of 24 weeks. They will receive the equipment necessary to perform the exercises as well as guidance on proper performance. They will also receive training in the Tiny Habits® Method at baseline and digital coaching for the duration of the study.

Behavioral: Bodyweight exercises (push-ups, angled-rows, bodyweight squats) on weekdays

Waitlist Control Arm

NO INTERVENTION

Participants in the control arm will be instructed to refrain from resistance training for the initial 12 weeks of the study. Note that, after the 12-week follow-up assessment (at which the primary outcome of composite reps will be assessed), this group will begin the RT program. They will receive the same equipment, training, and coaching as the intervention group, and they will continue the RT program for 12 weeks, followed by a 24-week assessment.

Interventions

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.

Intervention Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant
  • Participation in structured resistance training for ≥2 days/week, on average, during the past year.
  • Implanted medical device (e.g., pacemaker, defibrillator).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auburn University

Auburn, Alabama, 36832, United States

Location

Edward Via College of Osteopathic Medicine-Auburn Campus

Auburn, Alabama, 36832, United States

Location

Related Publications (4)

  • 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.

    PMID: 30418471BACKGROUND
  • 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/

    PMID: 30702833BACKGROUND
  • 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.

    PMID: 22777332BACKGROUND
  • 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.

Study Officials

  • Joshua C Hollingsworth, PharmD, PhD

    Edward Via College of Osteopathic Medicine (VCOM-Auburn)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researchers assessing outcomes as well as the researcher performing statistical analysis will be blinded to participants' group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 23, 2019

Study Start

November 11, 2019

Primary Completion

September 20, 2020

Study Completion

January 4, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations