Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04400279
Status:
COMPLETED
Last Update Posted:
2021-01-11
First Post:
2020-05-21
Brief Title:
The COVID-19 Pandemic and Exercise Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
COvid-19 Pandemic and Exercise COPE Trial A Randomized Study Examining Physical Activities and Wellbeing in Individuals Mandated to Stay at Home
Status:
COMPLETED
Status Verified Date:
2021-01
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:
COPE
Brief Summary:
The COPE Trial is a randomized controlled trial that will provide currently isolated yet generally physically healthy 18-64 year old adults who are pre-retirement with the opportunity to receive a free 3-month subscription to either a yoga or moderate-to-high intensity aerobic exercise app or be randomized to a waitlist control group Study outcomes include measures of psychological wellbeing and physical health
Detailed Description:
Global stay-at-home mandates implemented in response to the COVID-19 pandemic are having substantial negative effects on mental health Developing approaches to maintain the mental health of all individuals during this unprecedented time of physical distancing is of paramount importance In the proposed low cost randomized controlled trial RCT the investigators seek to answer whether the use of a mobile app that provides a variety of physical activities appropriate for home workouts ie high intensity interval training HIIT yoga can improve wellbeing and health in adults mandated to stay at home Should the results of this trial support the efficacy of the intervention via app delivery this has the potential to be implemented and delivered rapidly and at scale
Engaging in regular physical activity confers reduced risk for mental disorders eg depression anxiety in clinical and non-clinical populations The investigators recent evidence also suggests that becoming physically active reduces depressive symptoms as well as negative affect and rumination on a daily basis while improving daily positive affect and a sense of control in highly stressed adults With fitness centres currently closed by mandate becoming physically active during the COVID-19 pandemic could prove to be a challenge for individuals who are typically inactive those mandated to stay-at-home or those who do not have opportunities to access outdoor spaces that provide the recommended two meters of distance between people Thus the investigators seek to support those living under stay-at-home mandates with access to mobile apps that provide opportunities to be physically active in the home environment
The study will focus on physical activities requiring little physical space or equipment that are easily completed at home The study includes yoga a movement-based activity that promotes relaxation and mindfulness and only requires space for the full length and width of ones body and a mat as equipment Yoga has been shown to be effective in improving physical function and quality of life in RCTs The study also includes whole body weight WBW-based HIIT which also only requires a mat making it an excellent home-based form of aerobic exercise HIIT is characterized as bouts of high-intensity exercise combined with periods of recovery or lower intensity activity Its physical and psychological benefits compared to continuous moderate intensity training are often evidenced to be equal or significantly stronger
Aims The primary outcome will be a measure of depressive symptomology It is hypothesized that those who actively use the yoga andor WBW-HIIT mobile apps will improve in their depressive symptomatology compared to the waitlist control group over the course of the 6-week RCT The study will also include measures of as secondary outcomes psychological distress quality of life and self-reported physical health and expect decreases in distress and increases in the remaining outcomes The researchers will also investigate whether effects are stronger in those a who currently live alone vs live with others or b with poorer levels of psychological health pre-randomization
Engaging in regular physical activity confers reduced risk for mental disorders eg depression anxiety in clinical and non-clinical populations The investigators recent evidence also suggests that becoming physically active reduces depressive symptoms as well as negative affect and rumination on a daily basis while improving daily positive affect and a sense of control in highly stressed adults With fitness centres currently closed by mandate becoming physically active during the COVID-19 pandemic could prove to be a challenge for individuals who are typically inactive those mandated to stay-at-home or those who do not have opportunities to access outdoor spaces that provide the recommended two meters of distance between people Thus the investigators seek to support those living under stay-at-home mandates with access to mobile apps that provide opportunities to be physically active in the home environment
The study will focus on physical activities requiring little physical space or equipment that are easily completed at home The study includes yoga a movement-based activity that promotes relaxation and mindfulness and only requires space for the full length and width of ones body and a mat as equipment Yoga has been shown to be effective in improving physical function and quality of life in RCTs The study also includes whole body weight WBW-based HIIT which also only requires a mat making it an excellent home-based form of aerobic exercise HIIT is characterized as bouts of high-intensity exercise combined with periods of recovery or lower intensity activity Its physical and psychological benefits compared to continuous moderate intensity training are often evidenced to be equal or significantly stronger
Aims The primary outcome will be a measure of depressive symptomology It is hypothesized that those who actively use the yoga andor WBW-HIIT mobile apps will improve in their depressive symptomatology compared to the waitlist control group over the course of the 6-week RCT The study will also include measures of as secondary outcomes psychological distress quality of life and self-reported physical health and expect decreases in distress and increases in the remaining outcomes The researchers will also investigate whether effects are stronger in those a who currently live alone vs live with others or b with poorer levels of psychological health pre-randomization
Study Oversight
Has Oversight DMC:
None
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?:
None