Brief Title
Telehealth Support to Increase Physical Activity in Rett Syndrome
Official Title
Implementing Telehealth Support to Increase Physical Activity in Girls and Women With Rett Syndrome
Brief Summary
This study will recruit families with a daughter with Rett syndrome living in either
Australia, Denmark or Israel, and thereafter deliver individually designed participation
programs using telehealth strategies. We will evaluate the effectiveness of the programs on
reducing sedentary behaviours, increasing physical activity and increasing quality of life.
Detailed Description
This project will implement two intertwined strategies that will build the capacity of the
carer, clinical and therapy communities to support physical activity in Rett syndrome.
Individuals with Rett syndrome experience difficulties with movement and this can make it
difficult to participate in regular physical activity. Individuals with Rett syndrome need
support to participate in physical activities and it is important to work with primary
caregivers when developing strategies to support physical activity. We will conduct a
clinical trial that tests the effectiveness of working with primary caregivers to develop
strategies suitable to their lives that aim to increase participation in physical activity in
the individual with Rett syndrome whom they support. We will use a clinical trial design and
work with primary caregivers using Telehealth. We will test whether this approach decreases
sedentary time and increases physical activity. We will also test if there are changes in the
sleep, behaviour and quality of life. We aim to recruit 60 families for this study, 26 of
whom will live in Australia. Data from the three sites will be pooled for a stronger
analysis. We acknowledge that physical activity can be associated with a fall and therefore
our program will be developed with the primary caregiver to be suitable for their lives and
capacity to provide support. However, by practicing more activity, the individuals with Rett
syndrome could be stronger and risks of falling could be reduced. The risks for the
individual with Rett syndrome are therefore low. To let the Rett syndrome community know our
results, we will then develop an online resource documenting the physical activity program
and the evidence available to support it, and this will be freely available to families,
carers and therapists wherever they live in the world.
Study Type
Interventional
Primary Outcome
Average daily uptime (%)
Secondary Outcome
Sleep quality
Condition
Rett Syndrome
Intervention
Telehealth-delivered participation strategies to increase physical activity
Study Arms / Comparison Groups
Waitlist-Control Group
Description: The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
60
Start Date
January 1, 2020
Completion Date
September 1, 2021
Primary Completion Date
September 1, 2020
Eligibility Criteria
Inclusion Criteria:
- Genetically confirmed Rett syndrome
- Able to stand (with or without assistance)
- Live in Australia, Denmark or Israel
Exclusion Criteria:
- Individuals who have had spinal fusion over the previous 12 months
- Individuals who have had lower extremity orthopaedic surgery over the previous 6
months
Gender
All
Ages
5 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
Jenny Downs, PhD, +61 8 6319 1763, [email protected]
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04167059
Organization ID
RGS0000003371
Responsible Party
Sponsor
Study Sponsor
Telethon Kids Institute
Collaborators
Rigshospitalet, Denmark
Study Sponsor
Jenny Downs, PhD, Principal Investigator, Telethon Kids Institute
Verification Date
February 2020