Children With Cerebral Palsy Who Are AmbulantHOME-EXNCT07025694
Exercise Training Among Children With Cerebral Palsy to Increase Health and Well-being - A Feasibility Study
A study testing A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions., A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions and Moderate Intensity Continues Training in people with Children With Cerebral Palsy Who Are Ambulant and Cerebral Palsy GMFCS-ER I-II, run by Lund University at 1 site in Sweden.
Trial summary
The use of eHealth in children with cerebral palsy (CP) holds promise to increase participation in exercise. eHealth, has shown to increase accessibility to appropriate healthcare professionals as well as reduces time- and energy consuming transportation to/from physical appointments[5]. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Cerebral Palsy Who Are Ambulant, Cerebral Palsy GMFCS-ER I-II
- What is being tested?
- A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions., A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions and Moderate Intensity Continues Training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with CP-A defined as GMFCS-E\&R I-II
- children who are TD and not participating in any regular and planned leisure time physical exercise will be included in the study.
Who cannot join
- Ambulant children with CP walking with a walking aid (GMFCS-E\&R III);
- ambulant children who are TD with other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairment, or indigestion of regular medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Medical Faculty, Lund University
Lund, Skåne County, 223 62
Åsa B Tornberg, Associate Professor, +46-46222 97 66, asa.tornberg@med.lu.se
About this study
Official title: Feasibility Testing of a Homebased Exercise Intervention in Children With Cerebral Palsy Who Are Ambulant - The HOME-EX Study
The use of eHealth in children with cerebral palsy (CP) holds promise to increase participation in exercise. eHealth, has shown to increase accessibility to appropriate healthcare professionals as well as reduces time- and energy consuming transportation to/from physical appointments[5]. In children with CP reduced transportation to and from appointments, increased access to appropriate healthcare s professionals have shown to increase exercise.
However, the knowledge on how eHealth can support children with CP to participate in exercise is scarce and to the best of our knowledge there are no studies studying eHealth to increase exercise in children with CP. If HOME-EX research project is successful, we will unravel knowledge that will facilitate implementation of prescription of targeted, personalized exercise regimes to children with CP to enhance health and wellbeing and furthermore set a healthy lifestyle.
Read more
PURPOSE AND AIMS
The overall goal of the HOME-EX project is to develop, feasibility test, pilot the efficacy and map the conditions for future implement an eHealth application to support participation in exercise at home in children with CP who are ambulant (CP-A). The specific aims are:
Aim 1: From a pre-exciting eHealth-solution develop an application for Android-based tablet supporting exercise in the home of the children with CP-A in co-creation with children, family caregivers, professional caregivers, sports professionals and researchers.
Aim 2: Develop exercise sessions, as online supervised session and pre-video recorded sessions in co-creation with children, family caregivers, professional caregivers, sports professionals and researchers, to be delivered by the eHealth-solution.
Aim 3: To study the feasibility of the delivery of the exercise sessions from the eHealth-solution.
PROJECT DESCRIPTION Cerebral palsy (CP) is the most common physical disability in childhood, approximately 1.6/1000 children have CP with affected muscle tone, movement and motor skills, often accompanied by pain, epilepsy and intellectual, communicational and behavioural impairment.
The degree of motor impairment in CP is extremely variable and classified with the 5-level Gross Motor Function Classification System Expanded \& Revised (GMFCS-E\&R). Children with CP-A (GMFCS-E\&R level I-II) can either walk and/ stand independently.
Project management Since children are non-autonomous, the common point of departure for our research is the family; lifestyle changes as well as interventions must be implemented through the family. Feasibility testing aims to analyse clinical, procedural, and methodological uncertainties of the exercise testing and the exercise training interventions designed in co-creation with stakeholders. If no major changes are made to the study design and/or the intervention these children will be included into the piloting phase.
Recruitment In total, 20 children - 10 children with CP-A and 10 who are TD as healthy controls - aged between 10 to 16 years old will be recruited. The children in the two groups will be matched for age, BMI, and physical activity level.
Study 1: Addressing aim 1-2 - Development of an exercise-application Methodology: Workshops to further develop the eHealth app: Four separate workshops will then be conducted to discuss the functions and the setup of communication of the initial prototype, as well as how to deliver the exercise sessions and what they preferably may contain. Workshop 1 will consist of 4-6 children children with CP-A and TD. Workshop 2 will consist of family caregivers. Workshop 3 of professional caregivers as physiotherapists and workshop 4 of sport professionals as personal trainers. The workshops will employ a participatory approach, enabling active contributions from participants and be facilitated by researchers from the research group. After the workshops, the eHealth app will be updated by a technician based on the feedback received.
Study 2: Addressing aim 3 - Feasibility testing of an exercise-application Methodology: Four children in each group, in total eight children, will take part in the feasibility analysis. During the first three weeks will the children be supervised at schedule timepoints through an eHealth solution and during the last three weeks the children follows pre-recorded exercise sessions at a suitable time for the family.
After the first 6 weeks of exercise training procedural, clinical and methodological uncreates will be analysed. Feedback from the participants and their family-caregivers, will be collected through semi-structured interviews to evaluate the feasibility of the exercise training intervention. Depending on the findings during the feasibility testing, the exercise training intervention may change.
DATA ANALYS AND STATISTIC A mixed method approach will be used to meet the aims of the project and collect both quantitative and qualitative data.
- Being tested
- A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions., A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions, Moderate Intensity Continues Training, High intensity interval training
- Keywords
- Children, Cerebral Palsy, Exercise, Feasibility, MICT, HIIT, eHealth, Home based exercise
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions.Device
Also called Vidoecall exercise
Feasibility, acceptability and usability testing of delivering home-based exercise MICT and HIIT via a Vidoe-call at fixed time-points. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom.
A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventionsDevice
Also called Pre-recorded exercise
Feasibility, acceptability and usability testing of delivering home-based exercise MICT and HIIT via a pre-recorded videos at convenient time-point with at least one day in between during the periods of video-supervision
Moderate Intensity Continues TrainingOther
Also called MICT
The MICT exercise training on a spinning-bike will consist of moderate intensity-longer (60%Wpeak) duration exercise carried out 3 times per week. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom, and at time-point with at least one day in between during the periods of video-supervision. Exercise will consist of continuous biking at an individualized workload based on pre-exercise testing, for a total time of 30 minutes.
High intensity interval trainingOther
Also called HIIT
The HIIT exercise training on a spinning-bike will begin by using a protocol consisting of bouts of high-intensity (95%Wpeak) exercise lasting for 60 seconds. These bouts will be interspersed by 4 minutes of low intensity exercising (40%Wpeak). There will be 5 bouts per session. Exercise will consist of continuous biking at individualized workloads based on pre-exercise testing. The exercise will be carried out 3 times per week. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom, and at time-point with at least one day in between during the periods of video-supervision.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Plasy who are Ambulant (CP-A) | Other | Children with CP-A defined classified with the 5-level Gross Motor Function Classification System Expanded \& Revised (as GMFCS-E\&R) as GMFCS-E\&R I-II. Receives: Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions.; Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions; Other: Moderate Intensity Continues Training; Other: High intensity interval training |
| Children who are Typically Developted (TD) | Other | Ambulant children who are TD with no other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairment, or indigestion of regular medication. Receives: Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions.; Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions; Other: Moderate Intensity Continues Training; Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complaiance to the exercise regim
Number of exercise sessions performed
Measured: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Secondary outcomes (4)
Variance in the predefinde workload
Coefficient of variance during each exercise session assessed by the spinning bike.
Measured: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of adversed events due to illness
Number registered in the ehealth app
Measured: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of adverse avents due to technical issues
Number registered in the ehealth app
Measured: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Maximal exercise capacity
Indirect calorimetry will be used during a maximal incremental exercise test. The exercise test will be initiated by cycling on a cycle ergometer for 6 minutes at 30 W, followed by an increase of 10W/minute until exhaustion. The test will performed before and after each exercise period.
Exercise tests will be performed on a cycle ergometer (Monark 936, Monark Exercise AB, Vansbro, Sweden). An airtight mask covering the mouth and nose will be worn to measure breath-by-breath of VO2 and VCO2, for determination of maximal oxygen consumption (VO2peak), maximal workload (WRpeak), oxygen kinetics and Respiratory Exchange Ratio (RER) (Oxycon Mobile, Jaeger, Germany). Heart rate will be recorded continuously throughout the test (Polar, Finland).
Measured: From inclusion in the study undtil the last exercise test in total 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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 Children With Cerebral Palsy Who Are AmbulantStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Tornberg, Lund University
- Investigators
- Åsa B Tornberg, Associate Professor, Principal investigator, Department of Health Sciences, Medical Faculty, Lund Univeristy, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025694
- Sponsor's protocol ID
- LU_HOME-EX2025
- Acronym
- HOME-EX
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A small study group with risk of identification of individuals
Publications
Jakobsson T, Lauruschkus K, Johnsson BA, Andersson A, Hansson O, Holmberg R, Tornberg AB. Feasibility testing of a home-based exercise intervention in children with cerebral palsy who are ambulant-a study protocol of the HOME-EX study. Front Digit Health. 2026 May 12;8:1811789. doi: 10.3389/fdgth.2026.1811789. eCollection 2026.
PubMed 42206075
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Homebased Exercise Intervention in Children With Cerebral Palsy Who Are Ambulant - The HOME-EX Study
- ClinicalTrials.gov ID
- NCT07025694
- Acronym / sponsor ID
- HOME-EX / LU_HOME-EX2025
- Keywords
- Children, Cerebral Palsy, Exercise, Feasibility, MICT, HIIT, eHealth, Home based exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (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.
The use of eHealth in children with cerebral palsy (CP) holds promise to increase participation in exercise. eHealth, has shown to increase accessibility to appropriate healthcare professionals as well as reduces time- and energy consuming transportation to/from physical appointments[5]. In children with CP reduced transportation to and from appointments, increased access to appropriate healthcare s professionals have shown to increase exercise.
However, the knowledge on how eHealth can support children with CP to participate in exercise is scarce and to the best of our knowledge there are no studies studying eHealth to increase exercise in children with CP. If HOME-EX research project is successful, we will unravel knowledge that will facilitate implementation of prescription of targeted, personalized exercise regimes to children with CP to enhance health and wellbeing and furthermore set a healthy lifestyle.
PURPOSE AND AIMS
The overall goal of the HOME-EX project is to develop, feasibility test, pilot the efficacy and map the conditions for future implement an eHealth application to support participation in exercise at home in children with CP who are ambulant (CP-A). The specific aims are:
Aim 1: From a pre-exciting eHealth-solution develop an application for Android-based tablet supporting exercise in the home of the children with CP-A in co-creation with children, family caregivers, professional caregivers, sports professionals and researchers.
Aim 2: Develop exercise sessions, as online supervised session and pre-video recorded sessions in co-creation with children, family caregivers, professional caregivers, sports professionals and researchers, to be delivered by the eHealth-solution.
Aim 3: To study the feasibility of the delivery of the exercise sessions from the eHealth-solution.
PROJECT DESCRIPTION Cerebral palsy (CP) is the most common physical disability in childhood, approximately 1.6/1000 children have CP with affected muscle tone, movement and motor skills, often accompanied by pain, epilepsy and intellectual, communicational and behavioural impairment.
The degree of motor impairment in CP is extremely variable and classified with the 5-level Gross Motor Function Classification System Expanded \& Revised (GMFCS-E\&R). Children with CP-A (GMFCS-E\&R level I-II) can either walk and/ stand independently.
Project management Since children are non-autonomous, the common point of departure for our research is the family; lifestyle changes as well as interventions must be implemented through the family. Feasibility testing aims to analyse clinical, procedural, and methodological uncertainties of the exercise testing and the exercise training interventions designed in co-creation with stakeholders. If no major changes are made to the study design and/or the intervention these children will be included into the piloting phase.
Recruitment In total, 20 children - 10 children with CP-A and 10 who are TD as healthy controls - aged between 10 to 16 years old will be recruited. The children in the two groups will be matched for age, BMI, and physical activity level.
Study 1: Addressing aim 1-2 - Development of an exercise-application Methodology: Workshops to further develop the eHealth app: Four separate workshops will then be conducted to discuss the functions and the setup of communication of the initial prototype, as well as how to deliver the exercise sessions and what they preferably may contain. Workshop 1 will consist of 4-6 children children with CP-A and TD. Workshop 2 will consist of family caregivers. Workshop 3 of professional caregivers as physiotherapists and workshop 4 of sport professionals as personal trainers. The workshops will employ a participatory approach, enabling active contributions from participants and be facilitated by researchers from the research group. After the workshops, the eHealth app will be updated by a technician based on the feedback received.
Study 2: Addressing aim 3 - Feasibility testing of an exercise-application Methodology: Four children in each group, in total eight children, will take part in the feasibility analysis. During the first three weeks will the children be supervised at schedule timepoints through an eHealth solution and during the last three weeks the children follows pre-recorded exercise sessions at a suitable time for the family.
After the first 6 weeks of exercise training procedural, clinical and methodological uncreates will be analysed. Feedback from the participants and their family-caregivers, will be collected through semi-structured interviews to evaluate the feasibility of the exercise training intervention. Depending on the findings during the feasibility testing, the exercise training intervention may change.
DATA ANALYS AND STATISTIC A mixed method approach will be used to meet the aims of the project and collect both quantitative and qualitative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Plasy who are Ambulant (CP-A) | Other | Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions., Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions, Other: Moderate Intensity Continues Training, Other: High intensity interval trainingChildren with CP-A defined classified with the 5-level Gross Motor Function Classification System Expanded \& Revised (as GMFCS-E\&R) as GMFCS-E\&R I-II. |
| Children who are Typically Developted (TD) | Other | Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions., Device: A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions, Other: Moderate Intensity Continues Training, Other: High intensity interval trainingAmbulant children who are TD with no other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairment, or indigestion of regular medication. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with CP-A defined as GMFCS-E\&R I-II
- children who are TD and not participating in any regular and planned leisure time physical exercise will be included in the study.
Key exclusion criteria (2 listed)
- Ambulant children with CP walking with a walking aid (GMFCS-E\&R III);
- ambulant children who are TD with other neurological diagnoses, metabolic diagnoses, orthopaedic disabilities, asthma, heart diseases, cognitive impairment, or indigestion of regular medication.
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 |
|---|---|---|
| A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions.Also: Vidoecall exerciseFeasibility, acceptability and usability testing of delivering home-based exercise MICT and HIIT via a Vidoe-call at fixed time-points. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom. | Device | Children who are Typically Developted (TD), Children with Cerebral Plasy who are Ambulant (CP-A) |
| A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventionsAlso: Pre-recorded exerciseFeasibility, acceptability and usability testing of delivering home-based exercise MICT and HIIT via a pre-recorded videos at convenient time-point with at least one day in between during the periods of video-supervision | Device | Children who are Typically Developted (TD), Children with Cerebral Plasy who are Ambulant (CP-A) |
| Moderate Intensity Continues TrainingAlso: MICTThe MICT exercise training on a spinning-bike will consist of moderate intensity-longer (60%Wpeak) duration exercise carried out 3 times per week. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom, and at time-point with at least one day in between during the periods of video-supervision. Exercise will consist of continuous biking at an individualized workload based on pre-exercise testing, for a total time of 30 minutes. | Other | Children who are Typically Developted (TD), Children with Cerebral Plasy who are Ambulant (CP-A) |
| High intensity interval trainingAlso: HIITThe HIIT exercise training on a spinning-bike will begin by using a protocol consisting of bouts of high-intensity (95%Wpeak) exercise lasting for 60 seconds. These bouts will be interspersed by 4 minutes of low intensity exercising (40%Wpeak). There will be 5 bouts per session. Exercise will consist of continuous biking at individualized workloads based on pre-exercise testing. The exercise will be carried out 3 times per week. Tuesday, Thursday, Saturday during the 3 week-period of supervision via zoom, and at time-point with at least one day in between during the periods of video-supervision. | Other | Children who are Typically Developted (TD), Children with Cerebral Plasy who are Ambulant (CP-A) |
Primary outcome
Complaiance to the exercise regim
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of exercise sessions performed
4 secondary outcomes
Variance in the predefinde workload
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of adversed events due to illness
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Number of adverse avents due to technical issues
Time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.
Maximal exercise capacity
Time frame: From inclusion in the study undtil the last exercise test in total 20 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Derived from this study: PubMed 42206075Jakobsson T, Lauruschkus K, Johnsson BA, Andersson A, Hansson O, Holmberg R, Tornberg AB. Feasibility testing of a home-based exercise intervention in children with cerebral palsy who are ambulant-a study protocol of the HOME-EX study. Front Digit Health. 2026 May 12;8:1811789. doi: 10.3389/fdgth.2026.1811789. eCollection 2026.
- Individual participant dataSharing planned: No. A small study group with risk of identification of individuals
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.
Åsa B Tornberg, Associate Professor principal investigator
Department of Health Sciences, Medical Faculty, Lund Univeristy, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions., A eHealth application on a computer tablet contected to a secure severer with an interface on a computer to deliver exercise interventions and Moderate Intensity Continues Training in people with Children With Cerebral Palsy Who Are Ambulant and Cerebral Palsy GMFCS-ER I-II, run by Lund University at 1 site in Sweden.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Åsa B Tornberg, Associate Professor (+46-46-222 97 66, asa.tornberg@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complaiance to the exercise regim (time frame: From the start of exercise period 1 to the end of exercise period 2 in total 20 weeks.). 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 NCT07025694, 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 17 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.