Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-26 @ 6:51 PM
Study NCT ID:
NCT03759951
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2018-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II)
Sponsor:
University of Thessaly
Organization:
Study Overview
Official Title:
The Dose-response Effect of High-intensity Interval Neuromuscular Training on Health, Performance and Quality of Life in Overweight/Obese Adults: The DoIT Trial
Status:
COMPLETED
Status Verified Date:
2022-01
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:
None
Brief Summary:
Observing a lack of research investigating the chronic physiological and psychological responses to this type of exercise training the aim of this study is to investigate the optimal training configurations of DoIT to produce positive effects on health, performance and quality of life markers in sedentary overweight or obese adults aged 30-55 years. The DoIT program will be performed in a small-group setting indoor or outdoor implementing a progressive manner for 12 months and using bodyweight exercises with alternative modes.
Detailed Description:
This controlled, randomized, four-group, repeated-measures clinical trial will be consisted of the following stages:
1. Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
2. a 4-week adaptive period: based on a dietary analysis, participants will be given a dietary plan (considering the RMR and total daily physical activity related energy expenditure), providing an isocaloric diet over the initial 4-week adaptive period. During this adaptive period, volunteers will also be familiarized with exercises techniques and overload patterns that will be used throughout the study through 4 preparatory sessions.
3. At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
4. After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive recovery intervals.
5. After 12 months of exercise intervention all participants will participate in assessment procedures (post-training testing) at University facilities within 5 days after the completion of the last training session.
All participants will be randomly assigned to the following four groups:
1. Control group (no training)
2. DoIT-1 (1 session/week)
3. DoIT-2 (2 sessions/week)
4. DoIT-3 (3 sessions/week)
1. Initial testing: body weight and height, RMR, daily physical activity (PA), daily nutritional intake.
2. a 4-week adaptive period: based on a dietary analysis, participants will be given a dietary plan (considering the RMR and total daily physical activity related energy expenditure), providing an isocaloric diet over the initial 4-week adaptive period. During this adaptive period, volunteers will also be familiarized with exercises techniques and overload patterns that will be used throughout the study through 4 preparatory sessions.
3. At the end of the adaptation period, participants will participate in assessment procedures (baseline testing) at University facilities.
4. After the adaptive period all participants will be randomly assigned to four groups (control, 1 session/week, 2 sessions/week, 3 sessions/week). The exercise protocols that will be used throughout the 1-year intervention will be consisted of 8-12 neuromotor exercises in circuit fashion applying prescribed time (15-45 sec) of effort and passive recovery intervals.
5. After 12 months of exercise intervention all participants will participate in assessment procedures (post-training testing) at University facilities within 5 days after the completion of the last training session.
All participants will be randomly assigned to the following four groups:
1. Control group (no training)
2. DoIT-1 (1 session/week)
3. DoIT-2 (2 sessions/week)
4. DoIT-3 (3 sessions/week)
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?: