Viewing Study NCT04207567


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Study NCT ID: NCT04207567
Status: COMPLETED
Last Update Posted: 2021-04-19
First Post: 2019-12-16
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Minute Calisthenics: A Daily, Habit-Based, Bodyweight Resistance-Training Program
Sponsor: Edward Via Virginia College of Osteopathic Medicine
Organization:

Study Overview

Official Title: Minute Calisthenics: A Daily, Habit-Based, Bodyweight Resistance-Training Program
Status: COMPLETED
Status Verified Date: 2021-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 HabitsĀ® 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

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: