What is the clinical effectiveness of hydrotherapy in maintaining physical function in people with Duchenne muscular dystrophy?

ISRCTN	ISRCTN41002956
DOI	https://doi.org/10.1186/ISRCTN41002956
Secondary identifying numbers	16831

Submission date: 12/06/2014
Registration date: 12/06/2014
Last edited: 31/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Mrs Chin Maguire
Scientific

Health Services Research, School of Health & related Research (ScHARR) Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Email	c.maguire@sheffield.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	What is the clinical effectiveness of hydrotherapy in maintaining physical function in people with Duchenne muscular dystrophy?
Study acronym	Hydrotherapy for Duchenne Muscular Dystrophy (DMD)
Study hypothesis	Duchenne muscular dystrophy (DMD) is a rare disease mainly affecting boys. DMD causes muscle cells to gradually break down so that with time, a patients muscles become weak to the point where they are unable to conduct many of the activities they used to. There is no cure for this disease, but doctors and physiotherapists try to slow down its progression and the development of complications by prescribing steroids and a physical management programme. Clinical experience shows that physical activity helps to maintain functional abilities. Mostly physical management programmes are done on dry land. However they can also be performed in warm water, under supervision by a physiotherapist; this is known as 'hydrotherapy' or 'aquatic therapy'. Hydrotherapy enables affected people to perform exercises which may not be possible on land due to the support provided by the water. Additionally the activity is seen as fun for them and their carers. Despite this, hydrotherapy is difficult to access in many places in the UK. Many NHS trusts do not fund it or have not got the facilities to offer it. While we know people with DMD value hydrotherapy, we are not sure whether it really adds anything to land-based exercises alone in terms of helping with walking and other daily activities. We are therefore undertaking a small scale pilot study to help decide if a larger scale trial would be feasible and if so, how we should best conduct it.
Ethics approval(s)	14/EE/0204
Condition	Topic: Children, Genetics; Subtopic: All Diagnoses, Genetics Research and Congenital Disorders (all subtopics); Disease: Genetics Research and Congenital Disorders, All Diseases
Intervention	Participants will be allocated on a ratio of 1:1 using simple randomisation with permuted blinded block size to: 1. Control group to receive optimised land-based exercises (as defined by local community physiotherapy services and recorded by trial team) (n=20) 2. The intervention group will receive the same plus hydrotherapy (30 min, twice weekly, for 6 months: active assisted and/or passive stretching regime; simulated or real functional activities; sub-maximal exercise) (n=20) Study participants will be assessed for key outcome measures at 3 time points: consent and screen 1 visit; baseline visit; 26 week visit. We will collect information on a number of outcomes relating to the feasibility of conducting the trial which will include interviews with participants.
Intervention type	Other
Primary outcome measure	The feasibility of recruitment to the main trial
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/2014
Overall study end date	30/05/2015

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	Planned Sample Size: 40; UK Sample Size: 40
Participant inclusion criteria	1. Genetically or biopsy confirmed DMD 2. Age 7-16 years 3. Established on glucocorticosteroids 4. North Star Ambulatory Assessment score 8-34 (stable over 4 weeks) 5. Able to complete 10 metre walk (6 minute walk test)
Participant exclusion criteria	1.More than a 20% variation between baseline North Star Ambulatory Assessment scores 2.Unable to commit to the programme of twice weekly hydrotherapy for 6 months 3.Any absolute contraindications or precautions to hydrotherapy
Recruitment start date	01/12/2014
Recruitment end date	30/05/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Health Services Research, School of Health & related Research (ScHARR) Regents Court

Sheffield
S1 4DA
United Kingdom

Sponsor information

Sheffield Children's Hospital (UK)
Hospital/treatment centre

Western Bank
Sheffield
S10 2TH
England
United Kingdom

"ROR"	https://ror.org/05mshxb09

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/03/2017		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

31/03/2017: Publication reference added.