We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Movement Breaks in Real-World Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05574426
Recruitment Status : Not yet recruiting
First Posted : October 10, 2022
Last Update Posted : October 10, 2022
Sponsor:
Collaborators:
Canadian Cancer Society (CCS)
Canadian Institutes of Health Research (CIHR)
McMaster University
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

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.

Layout table for study information
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

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




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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05574426


Contacts
Layout table for location contacts
Contact: Sara McCreary 780-729-4587 smccrear@mail.ubc.ca

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jonathan Little University of British Columbia
Layout table for additonal 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    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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