The specific aims for this study are to identify whether a structured exercise programme:a. is feasible for people with HD, in terms of adherence, process and safetyb. improves physical fitness in people with HDc. improves physical function and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to assess feasibility of the exercise
intervention in terms of
adherence, safety and process. This will be achieved through the documentation
of adherence and
any adverse events, as well as any health-related changes such as falls,
hospital admissions, or
healthcare service use that occur during the intervention period. Duration of
participation and dropout
from the intervention will also be recorded. In order to assess benefits, a
range of outcomes that are
representative of participation, activities and body functions, as defined by
the World Health
Organisation Classification of Functioning, Disability and Health, will be
obtained. These will include
measures of physical fitness, cognitive ability, and motor function. Standard
clinical measures of
disease severity and function as well as health-related quality of life will
also be obtained.
Secondary outcome
-
Background summary
The efficacy of a long term exercise rehabilitation program on quality of life
and functioning in patients with Huntington's disease is unclear. In other
chronic conditions exercise rehabilitation proved to be efficacious on
parameters of well-being and functioning.
Study objective
The specific aims for this study are to identify whether a structured exercise
programme:
a. is feasible for people with HD, in terms of adherence, process and safety
b. improves physical fitness in people with HD
c. improves physical function and functioning in other domains, such as
cognition and quality of
life, in people with HD
Study design
The proposed trial is a single blind, exploratory phase II randomised,
controlled multi-site trial of an exercise-based intervention. A total of 42
participants will be recruited across five EHDN Registry/ENROLL sites: Cardiff,
Birmingham, Oxford, Leiden, and Muenster. Cardiff and Oxford sites
will each recruit 9 participants; Birmingham, Leiden and Muenster sites will
each recruit 8 participants.
Intervention
The intervention is an exercise-based intervention with an aerobic component,
three times per week
for 12 weeks.
Study burden and risks
1) Patients have to travel to Topaz Huntington Centrum Overduin in Katwijk 3
times a week for the duration of 12 weeks.
2) The risk of health deterioration is estimated low as the rehabilitation
program will performed at an aerobic level. Furthermore patients will be
supervised by trained physiotherapists on 20 out of 36 occasions.
Newport Road 30-36
Cardiff CF24 ODE
GB
Newport Road 30-36
Cardiff CF24 ODE
GB
Listed location countries
Age
Inclusion criteria
1) diagnosis of manifest HD, confirmed by genetic testing
2) above the age of 18
3) stable medication regime for four weeks prior to initiation of trial, and anticipated to be able to
maintain a stable regime for the course of trial
4) enrolled in EHDN Registry study
Exclusion criteria
1) any physical or psychiatric condition that would prohibit the participant from completing the
intervention or the full battery of assessments
2) inability to independently use the exercise bike
3) unable to understand or communicate in spoken English (UK sites only)
4) currently involved in any intervention trial or within four weeks of completing an intervention trial
5) current, regular participation in a structured exercise programme five times per week or more
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47421.058.13 |