Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445985
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-02-14
Brief Title:
Hydrotherapy in Duchenne Muscular Dystrophy DMD
Sponsor:
Lancashire Teaching Hospitals NHS Foundation Trust
Organization:
Lancashire Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Hydrotherapy for Health in Boys and Adolescents With Duchenne Muscular Dystrophy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial aims to establish if there are meaningful benefits to providing a hydrotherapy service for young people with Duchenne muscular dystrophy DMD The main aims are to 1 to allocate a clinical physiotherapist to a project implementing hydrotherapy in young patients with DMD to establish whether there are meaningful benefits to their daily life 2 to conduct patient and parent interviews to understand the barriers to completing a hydrotherapy intervention and ensure future research addresses meaningful outcomes for those with DMD
Detailed Description:
The quality of life in young males with Duchenne muscular dystrophy DMD is negatively impacted by daily pain changes in body composition and a lack of support to undertake physical activity Hydrotherapy represents a potential means of involving boys and adolescents with DMD in activity that could benefit the negative factors influencing their quality of life There are presently no guidelines or evidence for the benefits of hydrotherapy with the standards of care for young males with DMD
This trial will provide evidence that will allow care providers to advocate the use of hydrotherapy within the management of DMD as an inclusive activity that can be adopted by those with DMD who are either ambulatory or non-ambulatory Through 12-weeks of hydrotherapy the trial will investigate whether there are benefits to physical function pain and quality of life These measures represent meaningful outcomes in the progression of DMD and have direct patient impact for those affected by DMD On completion of the hydrotherapy there will be a series of interviews with some of the participants and their parents The aim of these interviews is to understand participant and parent barriers to hydrotherapy and uncover whether hydrotherapy improves the lives of the participants beyond simple clinical measures and questionnaires
The study aims recruit 44 boys and young men with Duchenne muscular dystrophy Patients will be recruited from NHS neuromuscular services and through families who attend the local hospice
Following an informed consent process they will enter the first 12 week stage as a control to observe and measure their habitual physical activity along with monitoring their diet They will then enter the intervention stage where they will have a weekly physiotherapy led pool session with a number of physical activities During the hydrotherapy period participants will access the hydrotherapy pool once a week for 12 weeks Sessions are supervised by an experienced physiotherapist who will guide the exercise for a session lasting 30 to 60 minutes
The exercises intensity and specific hydrotherapy plan will be derived from consultation with the participants and their parents Due to the variance within the presentation of the condition and the inclusive age range within the study an externally valid approach to exercise prescription will be utilised Diet and physical function will be measured during this stage
There will be a number of assessments to be completed at 3 time points As much as possible these will be arranged as single visits The first before the control period the second after the control period and the third after the hydrotherapy period The assessments include a number of physical assessments including assessments of function and ability body mass and quality of life After completion all participants will be invited to complete a qualitative interview in particular enquiring about the experience and logistics of hydrotherapy
This trial will provide evidence that will allow care providers to advocate the use of hydrotherapy within the management of DMD as an inclusive activity that can be adopted by those with DMD who are either ambulatory or non-ambulatory Through 12-weeks of hydrotherapy the trial will investigate whether there are benefits to physical function pain and quality of life These measures represent meaningful outcomes in the progression of DMD and have direct patient impact for those affected by DMD On completion of the hydrotherapy there will be a series of interviews with some of the participants and their parents The aim of these interviews is to understand participant and parent barriers to hydrotherapy and uncover whether hydrotherapy improves the lives of the participants beyond simple clinical measures and questionnaires
The study aims recruit 44 boys and young men with Duchenne muscular dystrophy Patients will be recruited from NHS neuromuscular services and through families who attend the local hospice
Following an informed consent process they will enter the first 12 week stage as a control to observe and measure their habitual physical activity along with monitoring their diet They will then enter the intervention stage where they will have a weekly physiotherapy led pool session with a number of physical activities During the hydrotherapy period participants will access the hydrotherapy pool once a week for 12 weeks Sessions are supervised by an experienced physiotherapist who will guide the exercise for a session lasting 30 to 60 minutes
The exercises intensity and specific hydrotherapy plan will be derived from consultation with the participants and their parents Due to the variance within the presentation of the condition and the inclusive age range within the study an externally valid approach to exercise prescription will be utilised Diet and physical function will be measured during this stage
There will be a number of assessments to be completed at 3 time points As much as possible these will be arranged as single visits The first before the control period the second after the control period and the third after the hydrotherapy period The assessments include a number of physical assessments including assessments of function and ability body mass and quality of life After completion all participants will be invited to complete a qualitative interview in particular enquiring about the experience and logistics of hydrotherapy
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 |
|---|---|---|---|
| 21PR1748 | OTHER | Health Research Authority | None |