Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04688255
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2020-12-23
Brief Title:
Mobile Subthreshold Exercise Program for Concussion--R01
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Randomized Controlled Trial Using Telehealth-delivered Rehabilitative Exercise to Treat Youth With Prolonged Concussion Recovery Mobile Subthreshold Exercise Program MSTEP-R01
Status:
RECRUITING
Status Verified Date:
2023-10
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:
MSTEP-R01
Brief Summary:
Approximately 19 million youth sustain a concussion each year and up to 30 experience persistent post-concussive symptoms PPCS such as headache dizziness and difficulty focusing that continue for weeks or months PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development cognitive function and academic success Previous recommendations for treating PPCS have focused on cognitive and physical rest but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS but access is challenging since most programs require weekly centralized visits with a concussion specialist To bridge this gap the investigators developed a telehealth-delivered approach to treat PPCS utilizing physical activity trackers Fitbits and weekly video conferences with trained research staff They then conducted a series of pilot studies with this approach finding excellent feasibility acceptability and evidence for more rapid declines in concussive symptoms compared to controls The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity MVPA and psychologic processes such as reducing fear- avoidance of concussive symptoms They now propose a fully-powered randomized controlled trial RCT to asses the efficacy of the Mobile Subthreshold Exercise Program M-STEP for treating youth with PPCS
Detailed Description:
The investigators will recruit n200 youth 11-18 years old with PPCS Youth will be randomized to 6 weeks of either usual care plus M-STEP intervention or usual care plus stretching control Youth in M-STEP will be coached through gradual increases in intensity and duration of rehabilitative exercise via weekly video conferencing Zoom and will use Fitbits to guide their progress Youth in the stretching group will act as attention controls All youth will complete research-grade measures at multiple time points Youth will be followed for a total of 6 months Data will be analyzed using mixed effects models to examine differences between experimental groups in the primary outcome trajectory of concussive symptoms and the secondary outcome changes over time in health-related quality of life on an intention-to-treat basis Potential mediators of the treatment effect will also be examined including fear-avoidance of concussive symptoms and MVPA and explore the impact of factors such as patient sex and parental protective behaviors
The investigators thus assert the following hypotheses
Hypothesis 1 M-STEP youth will have more rapid declines in HBI and improvement in PedsQL compared to control youth
Hypothesis 2 M-STEP youth will have greater increases in MVPA over time than control youth and these increases will predict more rapid improvement in HBI and PedsQL
Hypothesis 3 M-STEP youth will have steeper declines in fear-avoidance compared to control youth and these declines will predict more rapid improvement in HBI and PedsQL
IMPACT The proposed study will definitively answer the question of whether a mobile sub-threshold exercise program M-STEP improves outcomes for youth with PPCS It will also provide essential information about both the long-term impact of this intervention and potential mediators as well as biopsychosocial factors that influence treatment response The study design uses a rigorous protocolized smartphone administered mHealth intervention that will be readily reproducible and generalizable to the majority of youth with PPCS If successful this will be one of the few evidenced-based interventions available to treat youth with PPCS
The investigators thus assert the following hypotheses
Hypothesis 1 M-STEP youth will have more rapid declines in HBI and improvement in PedsQL compared to control youth
Hypothesis 2 M-STEP youth will have greater increases in MVPA over time than control youth and these increases will predict more rapid improvement in HBI and PedsQL
Hypothesis 3 M-STEP youth will have steeper declines in fear-avoidance compared to control youth and these declines will predict more rapid improvement in HBI and PedsQL
IMPACT The proposed study will definitively answer the question of whether a mobile sub-threshold exercise program M-STEP improves outcomes for youth with PPCS It will also provide essential information about both the long-term impact of this intervention and potential mediators as well as biopsychosocial factors that influence treatment response The study design uses a rigorous protocolized smartphone administered mHealth intervention that will be readily reproducible and generalizable to the majority of youth with PPCS If successful this will be one of the few evidenced-based interventions available to treat youth with PPCS
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD094722-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HD094722-01A1 |