Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551441
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-19
Brief Title:
Cardiopulmonary Adaptations to High-intensity Interval Training HIIT in COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cardiopulmonary Adaptations to High-intensity Interval Training HIIT in COPD a Randomized Controlled Trial the COPDEX Study
Status:
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:
COPDEX
Brief Summary:
The aim of this prospective randomised controlled trial in which the impact of high intensity interval training HIIT on pulmonay blood volume pulmonary gas exchange during exercise and lung tissue mass
The primary objective is to investigate whether 6 months of supervised HIIT leads to an increase in pulmonary blood volume in patients with COPD with a concomitant improvement in pulmonary gas exchange
Key objectives are to determine whether an increase in pulmonary blood volume is associated with the formation of new lung tissue Other secondary objectives include investigating the effect of supervised HIIT on formation of lung tissue symptom severity pulmonary gas exchange at supine rest and on pulmonary blood volume at rest Finally exploratory objectives include investigating the effects of HIIT on lung function VO2peak functional outcomes body composition blood samples and cardiac output
Participants will be randomly allocated 11 stratified by sex to either
1 24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or
2 A control group who will not undergo HIIT training The control group will be encouraged not to change their exercise or eating habits
The participants will visit the clinic pre- and post the intervention Exercise habits adverse events hospital admisseions infections and medications will be assessed by phone at week 4 8 12 16 20 and at follow-up visit All participants will undergo 24-h accelerometry for five consecutive days to measure posture allocation and daily physical activity behavior The devices will be attached just before the randomization after one month at 12 weeks and just before the 6 months testing
The primary objective is to investigate whether 6 months of supervised HIIT leads to an increase in pulmonary blood volume in patients with COPD with a concomitant improvement in pulmonary gas exchange
Key objectives are to determine whether an increase in pulmonary blood volume is associated with the formation of new lung tissue Other secondary objectives include investigating the effect of supervised HIIT on formation of lung tissue symptom severity pulmonary gas exchange at supine rest and on pulmonary blood volume at rest Finally exploratory objectives include investigating the effects of HIIT on lung function VO2peak functional outcomes body composition blood samples and cardiac output
Participants will be randomly allocated 11 stratified by sex to either
1 24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or
2 A control group who will not undergo HIIT training The control group will be encouraged not to change their exercise or eating habits
The participants will visit the clinic pre- and post the intervention Exercise habits adverse events hospital admisseions infections and medications will be assessed by phone at week 4 8 12 16 20 and at follow-up visit All participants will undergo 24-h accelerometry for five consecutive days to measure posture allocation and daily physical activity behavior The devices will be attached just before the randomization after one month at 12 weeks and just before the 6 months testing
Detailed Description:
None
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