Telehealth Support to Increase Physical Activity in Rett Syndrome

NCT04167059 | Unknown DMC

• 1 other identifier: RGS0000003371
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Rett Syndrome

Keywords

Sedentary behaviour; Physical activity; Quality of life; Telehealth

Outcome Measures

Primary Outcomes (2)

• Average daily uptime (%)

  Percentage of time spent active (uptime) over total awake time, measured with an ActivPAL

  Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks

• Average daily step count

  Number of daily steps measured by Stepwatch Activity Monitor

  Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks

Secondary Outcomes (3)

• Sleep quality

  Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks

• Behaviour

  Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks

• Child Quality of Life

  Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks

Study Arms (2)

Waitlist-Control Group

EXPERIMENTAL

The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.

Behavioral: Telehealth-delivered participation strategies to increase physical activity

Immediate Treatment

EXPERIMENTAL

The 'immediate treatment' group will receive the 12-week intervention period first, followed by 12 week non-intervention period.

Behavioral: Telehealth-delivered participation strategies to increase physical activity

Interventions

Telehealth-delivered participation strategies to increase physical activity BEHAVIORAL

Therapists and primary caregivers will meet online on 6 occasions at fortnightly intervals over a 12 week period. Sessions will enable the development of strategies that will aim to increase the amount the participant stands and walks. Throughout, the therapists and primary caregivers will discuss physical activity needs, determine relevant activities, modify the program as necessary and plan additional goals.

Immediate Treatment; Waitlist-Control Group

Eligibility Criteria

• Age: 5 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Genetically confirmed Rett syndrome
• Able to stand (with or without assistance)
• Live in Australia, Denmark or Israel

You may not qualify if:

• Individuals who have had spinal fusion over the previous 12 months
• Individuals who have had lower extremity orthopaedic surgery over the previous 6 months

Sponsors & Collaborators

• Telethon Kids Institute: lead
• Rigshospitalet, Denmark: collaborator
• Ariel University: collaborator
• University of Haifa: collaborator

Study Sites (2)

Center for Rett Syndrom, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Ari'el University

Ari’el, Israel

RECRUITING

Related Publications (1)

• Downs J, Lotan M, Elefant C, Leonard H, Wong K, Buckley N, Stahlhut M. Implementing telehealth support to increase physical activity in girls and women with Rett syndrome-ActivRett: protocol for a waitlist randomised controlled trial. BMJ Open. 2020 Dec 29;10(12):e042446. doi: 10.1136/bmjopen-2020-042446.

  PMID: 33376177 DERIVED

MeSH Terms

Conditions

Rett Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System; Behavior

Study Officials

• Jenny Downs, PhD

  Telethon Kids Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Downs, PhD

CONTACT

+61 8 6319 1763; Jenny.Downs@telethonkids.org.au

Nicholas Buckley, BSc(Hons)

CONTACT

+61 8 6319 1771; nicholas.buckley@telethonkids.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: We note that our primary outcomes of sedentary behaviours and physical activity will be measured objectively by physical activity devices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We are using a waitlist controlled trial study design. Group membership will be determined using a concealed allocation randomisation after the baseline assessment. The 'immediate treatment' group will receive the 12-week intervention period following the assessment at baseline followed by a 12 week non-intervention period. The 'waitlist control' group receive no intervention in the first 12 week period and will then receive the intervention in the second 12 week period.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: January 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); IL (1)