Rett SyndromeActivRettNCT04167059
Telehealth Support to Increase Physical Activity in Rett Syndrome
A study testing Telehealth-delivered participation strategies to increase physical activity in people with Rett Syndrome, run by Telethon Kids Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- Telehealth-delivered participation strategies to increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Genetically confirmed Rett syndrome
- Able to stand (with or without assistance)
- Live in Australia, Denmark or Israel
Who cannot join
- Individuals who have had spinal fusion over the previous 12 months
- Individuals who have had lower extremity orthopaedic surgery over the previous 6 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Center for Rett Syndrom, Rigshospitalet
Copenhagen, 2100
Michelle Stahlhut, PhD, +45 29 20 48 49, michelle.stahlhut@regionh.dk
Israel1 site, 1 recruiting
- Recruiting
Ari'el University
Ari’el
Meir Lotan, PhD, ml_pt_rs@013net.net
About this study
Official title: Implementing Telehealth Support to Increase Physical Activity in Girls and Women With Rett Syndrome
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.
Read the 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.
- Conditions
- Rett Syndrome
- Being tested
- Telehealth-delivered participation strategies to increase physical activity
- Keywords
- Sedentary behaviour, Physical activity, Quality of life, Telehealth
- Medical subject headings
- Rett Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-delivered participation strategies to increase physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist-Control Group | Experimental | The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period. Receives: 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. Receives: Behavioral: Telehealth-delivered participation strategies to increase physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily uptime (%)
Percentage of time spent active (uptime) over total awake time, measured with an ActivPAL
Measured: 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
Measured: Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks
Secondary outcomes (3)
Sleep quality
Sleep Disturbance Scale for Children.
Measured: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Behaviour
Rett Syndrome Behaviour Scale
Measured: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Child Quality of Life
Quality of Life Inventory-Disability (QI-Disability)
Measured: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Jan 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Ariel University, University of Haifa
- Responsible party
- Sponsor
- Investigators
- Jenny Downs, PhD, Principal investigator, Telethon Kids Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167059
- Sponsor's protocol ID
- RGS0000003371
- Acronym
- ActivRett
- Status last verified
- Feb 2020
- First submitted
- 14 Nov 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33376177
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Telehealth Support to Increase Physical Activity in Girls and Women With Rett Syndrome
- ClinicalTrials.gov ID
- NCT04167059
- Acronym / sponsor ID
- ActivRett / RGS0000003371
- Conditions
- Rett Syndrome
- Keywords
- Sedentary behaviour, Physical activity, Quality of life, Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Ariel University, University of Haifa
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Waitlist-Control Group | Experimental | Behavioral: Telehealth-delivered participation strategies to increase physical activityThe 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period. |
| Immediate Treatment | Experimental | Behavioral: Telehealth-delivered participation strategies to increase physical activityThe 'immediate treatment' group will receive the 12-week intervention period first, followed by 12 week non-intervention period. |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Genetically confirmed Rett syndrome
- Able to stand (with or without assistance)
- Live in Australia, Denmark or Israel
Key exclusion criteria (2 listed)
- Individuals who have had spinal fusion over the previous 12 months
- Individuals who have had lower extremity orthopaedic surgery over the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth-delivered participation strategies to increase physical activityTherapists 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. | Behavioural | Immediate Treatment, Waitlist-Control Group |
Primary outcome
Average daily uptime (%)
Time frame: Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks
Percentage of time spent active (uptime) over total awake time, measured with an ActivPAL
Average daily step count
Time frame: Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks
Number of daily steps measured by Stepwatch Activity Monitor
3 secondary outcomes
Sleep quality
Time frame: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Behaviour
Time frame: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Child Quality of Life
Time frame: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 33376177Downs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Downs, PhD principal investigator
Telethon Kids Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-delivered participation strategies to increase physical activity in people with Rett Syndrome, run by Telethon Kids Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Downs, PhD (+61 8 6319 1763, Jenny.Downs@telethonkids.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily uptime (%) (time frame: Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.