Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554665
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Effects of HIIT on Bone Metabolism in Individuals With Chronic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of High-intensity Interval Training on Bone Metabolism in Individuals With Chronic Stroke a Proof-of-concept Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Objectives To investigate the effects of high-intensity interval training HIIT on bone metabolism in chronic stroke survivors
Hypothesis to be tested HIIT performed on a recumbent stepper will yield significantly improved results on bone turnover markers in chronic stroke survivors when compared with moderate-intensity continuous training MICT Design and subjects Single-blinded stratified randomised placebo-controlled clinical trial involving 66 chronic stroke survivors who meet our inclusion criteria
Interventions Participants will be randomly allocated to either HIIT MICT or a stretching group active control HIIT and MICT interventions will be performed 3 times per week for 12 consecutive weeks giving a total of 36 training sessions
Main outcome measures Evaluations will be conducted at baseline at the end of the intervention week 12 and at an 12-week follow-up week 24 Primary outcome measures will include bone turnover markers Secondary outcome measures will include muscle biochemical markers inflammatory markers the Neurological Fatigue Index for stroke cardiopulmonary function handgrip strength the 5-times sit-to-stand the Fugl-Meyer Motor Assessment the 6-Minute Walking Test the 10-Meter Walking Test the Mini Balance Evaluation Systems Test the Activities-Specific Balance Confidence Scale the Physical Activity Enjoyment Scale the Behavioural Regulation Exercise Questionnaire
Hypothesis to be tested HIIT performed on a recumbent stepper will yield significantly improved results on bone turnover markers in chronic stroke survivors when compared with moderate-intensity continuous training MICT Design and subjects Single-blinded stratified randomised placebo-controlled clinical trial involving 66 chronic stroke survivors who meet our inclusion criteria
Interventions Participants will be randomly allocated to either HIIT MICT or a stretching group active control HIIT and MICT interventions will be performed 3 times per week for 12 consecutive weeks giving a total of 36 training sessions
Main outcome measures Evaluations will be conducted at baseline at the end of the intervention week 12 and at an 12-week follow-up week 24 Primary outcome measures will include bone turnover markers Secondary outcome measures will include muscle biochemical markers inflammatory markers the Neurological Fatigue Index for stroke cardiopulmonary function handgrip strength the 5-times sit-to-stand the Fugl-Meyer Motor Assessment the 6-Minute Walking Test the 10-Meter Walking Test the Mini Balance Evaluation Systems Test the Activities-Specific Balance Confidence Scale the Physical Activity Enjoyment Scale the Behavioural Regulation Exercise Questionnaire
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