Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628011
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Digital Follow-up of Aerobic Interval Training in Outpatients With Mental Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital Follow-up of Exercise Training in Outpatients With Mental Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIG-EX
Brief Summary:
This randomized-controlled trial RCT will investigate if digital follow-up of exercise ie followup through the new citizen portal HelsaMi coupled with an exercise app can result in exercise adherence and improved oxygen uptake in individuals with mental disorders MD Secondary the project will provide information regarding effects on cardiovascular disease risk-factors functional capacity quality of life satisfaction and cost through a randomized-controlled trial RCT including individuals with MDs
Outcomes assessed in this project such as maximal oxygen uptake functional capacity and quality of life are strongly related to the ability to carry out activities of daily living These outcomes are associated with benefits such as reduced sick leave extended life expectancy independence and improved health status with increasing age Economically with the world population growing older and health care resources being stretched there is clearly a need to apply and evaluate effective alternative methods to improve somatic health on a broader scale in a sustainable fashion preferably utilizing existing platforms and exercise apps
Outcomes assessed in this project such as maximal oxygen uptake functional capacity and quality of life are strongly related to the ability to carry out activities of daily living These outcomes are associated with benefits such as reduced sick leave extended life expectancy independence and improved health status with increasing age Economically with the world population growing older and health care resources being stretched there is clearly a need to apply and evaluate effective alternative methods to improve somatic health on a broader scale in a sustainable fashion preferably utilizing existing platforms and exercise apps
Detailed Description:
The main aim of this randomized controlled trial RCT is to investigate if digital exercise followup can support exercise adherence and result in increased aerobic capacity in individuals with MDs We will assess the short-term effects through a 12-week intervention and its long-term effects after 1-year Both the intervention group IG and control group CG will receive two sessions of aerobic interval training at the Exercise Training Clinic situated at the Department of Psychosis and Rehabilitation Psychiatry Clinic St Olavs Hospital Trondheim University Hospital Trondheim Norway One training session consists of 36 minutes of high intensity training HIT HIT consists of 4x4 intervals on a treadmill at 85-95 of maximal heart rate interspersed by 3minute active rest periods at 70 maximal heart rate 31 Following the educational exercise sessions at the Exercise Training Clinic the IG will be encouraged to perform two aerobic interval training sessions per week for 12 weeks on their own and not at the exercise training clinic while receiving digital follow-up support through HelsaMi and exercise guidance through the exercise app The digital follow-up through HelsaMi will consist of overview of treatment progress and schedule communication with health care personnel video consultation or chat up to 2 times per week notifications reminding them to exercise exercise diary questionnaires and educational content
Objective To investigate if digital exercise follow-up through HelsaMi combined with an exercise app Myworkout GO in individuals with MDs is more effective at improving exercise adherence and aerobic capacity compared to standard treatment coupled with advice on how to perform high intensity interval training without any digital follow-up
Main hypothesis Digital follow-up of exercise yields better results than only being advised to exercise at improving exercise adherence peak oxygen uptake V O2peak work efficiency functional capacity and quality of life after 12 weeks and 1-year
Objective To investigate if digital exercise follow-up through HelsaMi combined with an exercise app Myworkout GO in individuals with MDs is more effective at improving exercise adherence and aerobic capacity compared to standard treatment coupled with advice on how to perform high intensity interval training without any digital follow-up
Main hypothesis Digital follow-up of exercise yields better results than only being advised to exercise at improving exercise adherence peak oxygen uptake V O2peak work efficiency functional capacity and quality of life after 12 weeks and 1-year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None