Efficacy of Movement Breaks in Real-World Settings

• ClinicalTrials.gov Identifier: NCT05574426
• Recruitment Status: Not yet recruiting
• First Posted: October 10, 2022
• Last Update Posted: October 10, 2022
• Sponsor: University of British Columbia
• Collaborators: Canadian Cancer Society (CCS); Canadian Institutes of Health Research (CIHR); McMaster University
• Information provided by (Responsible Party): Jonathan Little, University of British Columbia

Study Description

Brief Summary:

The purpose of this study is to determine the efficacy of performing "exercise snacks" (short movement breaks throughout the day) on various measures of cardiometabolic health.

Condition or disease	Intervention/treatment	Phase
Healthy	Behavioral: Movement Breaks	Not Applicable

Detailed Description:

After being informed about the study and potential risks, all eligible participants who have provided consent will undergo a baseline visit to assess pre-intervention basic anthropometrics, cardiorespiratory fitness, and provide a blood sample. Participants will then be randomized in a 1:1 ratio to one of two groups: 1) Mobility movement breaks (stretching or range of motion exercises); or 2) Cardiovascular movement breaks (designed to raise heart rate). Both groups will be encouraged to perform 3-4 daily movement breaks on at least 3 days of the week with support from an online platform and app that provides video instructions and reminders to complete the movement breaks. After 12 weeks, participants will be asked to return to the lab for the same testing performed at baseline.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized (1:1 allocation ratio) into Mobility or Cardiovascular movement break groups for 12-weeks. Both groups will perform 3-4 movement breaks on at least 3 days of the week.
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors will not be aware of group allocation and statistics performed on data with group identity blinded.
• Primary Purpose: Prevention
• Official Title: Efficacy of Movement Breaks in Real-World Settings
• Estimated Study Start Date: October 2022
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cardiovascular Movement Breaks; Participants will perform 3-4 exercise snacks (30-60s bursts of exercise) on at least 3 days of the week. The exercises prescribed in this arm will be designed to increase heart rate.	Behavioral: Movement Breaks; Participants will be asked to perform 30-60 second movement breaks 3-4 times per day on at least 3 days per week.; Other Name: Activity Snacks
Active Comparator: Mobility Movement Breaks; Participants will perform 3-4 mobility snacks (30-60s of mobility exercises or stretching) on at least 3 days of the week. The exercises prescribed in this arm are not designed to increase heart rate.	Behavioral: Movement Breaks; Participants will be asked to perform 30-60 second movement breaks 3-4 times per day on at least 3 days per week.; Other Name: Activity Snacks

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Cardiorespiratory Fitness at 12 Weeks [ Time Frame: Baseline and Week 12 ]
   Cardiorespiratory fitness will be assessed as the highest 30-s average from a laboratory-based graded VO2peak test on a cycle ergometer.

Secondary Outcome Measures :

1. Change from Baseline in Plasma Insulin [ Time Frame: Baseline and 12 weeks ]
   A fasted venous blood sample will be obtained and insulin measured by commercial assay.
2. Change from Baseline in Plasma Glucose [ Time Frame: Baseline and 12 weeks ]
   A fasted venous blood sample will be obtained and glucose measured by biochemical assay.
3. Change from Baseline in Insulin Resistance [ Time Frame: Baseline and 12 weeks ]
   A fasted venous blood sample will be obtained and insulin resistance estimated by homeostasis model assessment (HOMA) score
4. Change from Baseline in Inflammatory cytokines [ Time Frame: Baseline and 12 weeks ]
   A fasted venous blood sample will be obtained and inflammatory cytokines measured by multiplex assay
5. Change from Baseline in Body Mass [ Time Frame: Baseline and 12 weeks ]
   Body mass will be measured by weigh scale
6. Change from Baseline in Waist Circumference [ Time Frame: Baseline and 12 weeks ]
   Waist circumference (in centimetres) will be measured using a measurement tape.
7. Device-Measured Adherence to Movement Breaks [ Time Frame: Week 2 and week 11 ]
   Participants will wear accelerometers to assess adherence near the beginning and the end of the intervention.
8. Self-Reported Adherence to Movement Breaks [ Time Frame: Once per week for 12 weeks ]
   Participants will be sent weekly surveys asking them to recall the total number of movement breaks performed that week.
9. Movement Break Enjoyment assessed by the Exercise Enjoyment Scale (EES) [ Time Frame: Immediately following each movement break for entire 12-week intervention ]
   The EES is a validated, single-item 7-point scale to assess exercise enjoyment. Possible scores range from 1 (not at all) to 7 (extremely).
10. Rating of Perceived Exertion (RPE) following Movement Breaks [ Time Frame: Immediately following each movement break for entire 12-week intervention ]
    A 10 point RPE scale will be used to assess perceived exertion ranging from 0 (rest) to 10 (maximal).

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Physically inactive (performing <150 minutes of moderate-to-vigorous intensity aerobic exercise per week, assessed by pre-screening Get Active Questionnaire);
2. Body Mass Index: 18.5-30.0 kg/m2;
3. Not currently diagnosed with or being treated for cardiometabolic disease (e.g., coronary artery disease, diabetes);
4. Not a current smoker;
5. Cleared to engage in physical activity using the Get Active Questionnaire and, if applicable, consultation with a Qualified Exercise Professional;
6. Access to a computer, tablet or smartphone for intervention delivery and tracking

Exclusion Criteria:

1. Chronic health condition preventing participation in exercise;
2. Lack of access to internet connection

Contacts and Locations

Contacts

Contact: Sara McCreary; 780-729-4587; smccrear@mail.ubc.ca

Locations

Canada, British Columbia

University of British Columbia

Kelowna, British Columbia, Canada, V1V 1V7

Contact: Sara McCreary 780-729-4587 smccrear@mail.ubc.ca

Sponsors and Collaborators

University of British Columbia

Canadian Cancer Society (CCS)

Canadian Institutes of Health Research (CIHR)

McMaster University

Investigators

• Principal Investigator: Jonathan Little; University of British Columbia

More Information

• Responsible Party: Jonathan Little, Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT05574426
• Other Study ID Numbers: H21-03417; 707246 ( Other Grant/Funding Number: Canadian Cancer Society ); POC-181042 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
• First Posted: October 10, 2022
• Last Update Posted: October 10, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan Little, University of British Columbia:

Exercise Snack; Movement Break; Sedentary Time; Lifestyle Exercise; Physical Activity Breaks; VILPA