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Physical InactivityPAPNCT05867940

Effects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities

A study testing Physical activity on prescription in people with Physical Inactivity and Cerebral Palsy, run by Region Skane at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Physical inactivity is an increasing problem in the general population in society. However, in people with disabilities, inactivity is even more frequently reported. Physical activity on prescription (PAP) is a well-established method to enhance physical activity. Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Physical Inactivity, Cerebral Palsy, Autism
What is being tested?
Physical activity on prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSweden
Study dates
5 Jun 2023to 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 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Physical inactivity
  • Not meeting the physical activity recommendations
  • Much sedentary time
  • Physical disability
  • Intellectual disability
  • Autism
  • Living in the Skåne Region in Sweden
  • Receiving treatment from the habilitation Services in the Skåne Region, Sweden

Who cannot join

  • Meeting the physical activity recommendations

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katarina Lauruschkus, PhD contact

+46 707519888

katarina.lauruschkus@med.lu.se

Annika Lundkvist Josenby, PhD contact

+4646178386

annika.lundkvistjosenby@skane.se

Sweden1 site, 1 recruiting
  • Department of habilitation, Region Skåne, Sweden

    Malmö, 21174

    Katarina Lauruschkus, PhD, +46707619888, katarina.lauruschkus@skane.se

    Gisela Teltscher, RPT, +4641058626, gisela.teltscher@skane.se

    Recruiting

Other trials in Sweden

About this study

Official title: Effects of Physical Activity on Prescription (PAP) as an Individualised and Health-enhancing Intervention for Children, Adolescents and Adults With Different Disabilities Including Health Economic Analysis

Physical inactivity is an increasing problem in the general population in society. However, in people with disabilities, inactivity is even more frequently reported. Physical activity on prescription (PAP) is a well-established method to enhance physical activity. The prescribed physical activity can be activities such as walking, cycling, swimming, or gardening, and should be performed over a longer period. In children with cerebral palsy, PAP has shown to be feasible to increase participation in physical activity and to reduce sedentary behaviour, and the habilitation services in the Region of Skåne have decided to offer PAP to all children and youth with disabilities. It is of great importance to study these interventions when applied on a broader group of patients than previously studied.

The aim is to study the effects of an individualised and health-enhancing intervention in physically inactive people with autism, intellectual and physical disabilities. Also, the cost-effectiveness of PAP will be studied.

60 physically inactive children, aged 8- 17 years, and 20 adults, with autism, intellectual or physical disability will be included. The participants are recruited by their clinical physiotherapists, who also will be carrying out the PAP-intervention. The self-selected physical activity/activities may either be a physical activity organized by a club and/or an everyday activity such as walking a dog or riding a bicycle to school. Each participant fills in an activity logbook. Motivational interviewing will be used to support the participants. The Canadian Occupational Performance Measure can be used to identify what activities the participants are motivated to do, and to detect changes in the participants' perception of their performance of the activity. Quality of life will be monitored. Physical activity will be measured through the International Physical Activity Questionnaire (IPAQ) and a movement monitor (accelerometer). Study specific questionnaires will be filled in regarding costs and background information. Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne. Data will be collected at 3 months prior to the intervention, just before the intervention starts, when the intervention is finished, and at 6, 12 and 24 months after the intervention. The study has been approved by the Swedish Ethical Review Authority.

Read the detailed description

Introduction:

Physical inactivity is an increasing problem in the general population in society. However, in people with disabilities, inactivity is even more frequently reported. Physical activity on prescription (PAP) is a well-established method to enhance physical activity in adults in primary care. The prescribed physical activity should lead to moderate increase of the pulse, such as walking, cycling, swimming, or gardening, and should be performed over a longer period in order to achieve a change towards a more active lifestyle. The activity may be prescribed by a physiotherapist, physician, nurse, or other health professional. In children with cerebral palsy, PAP has shown to be feasible to increase participation in physical activity and to reduce sedentary behaviour, and the habilitation services in the Region of Skåne have decided to offer PAP as an activity-enhancing intervention to all children and youth with disabilities. It is of great importance to study these interventions when applied on a broader group of patients (diagnoses and ages) than previously studied.

Aim:

The aim is to study feasibility as well as health effects of an individualised and health-enhancing intervention in physically inactive people with autism, intellectual or physical disabilities in the Department of Habilitation in the Region of Skåne. Also, cost-effectiveness of the intervention PAP will be studied using health-economic analysis methods.

Material:

In total 60 children, aged 8- 17 years; 20 physically inactive children in each group with autism, intellectual and physical disability will be included. Also, 20 physically inactive adults, aged 18 years and older, with any of the disabilities mentioned above, will be recruited for this intervention study.

Method:

Participants are recruited to this study by their clinical physiotherapists, who also will be carrying out the intervention with their patient in ordinary praxis. The selected activity should be adapted to the individual's interests, functional limitations and resources, and may either be a physical activity organized by a club and/or an everyday activity such as walking a dog or riding a bicycle to school. Each participant should report the dates and length of all activities during the 12 weeks that the study will last in an activity logbook.

Measures:

  • Motivational interviewing will be used to support the health enhancing change in lifestyle that PAP is expected to contribute to.
  • The participants will be questioned about the amount of physical activity using the International Physical Activity Questionnaire (IPAQ) and will be using an accelerometer to objectively measure the activity during a full week (7 days).
  • The Canadian Occupational Performance Measure (COPM) can be used to identify what activities the participants are motivated to do, and to detect changes in the participants perception of his/her performance of the activity.
  • The Goal Attainment Scaling (GAS) is used for goal setting. GAS is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculate the extent to which a patient's goals are met.
  • The participants' perception of health-related quality of life will be monitored using the EuroQol Five-Dimensional Questionnaire, Youth Version (EQ-5D-Y) or EuroQol Five-Dimensional Questionnaire, five-level version for adults (EQ-5D-5L).
  • To analyze the costs of the intervention, participants themselves and/or parents will be asked to report level of education, occupation, income, family constitution as well as direct or indirect costs for the selected activity. Also, the physiotherapists will report the amount of hours spent to prepare and carry out the activity as well as evaluate/measure the outcome of the intervention for each participant.

The questionnaires directed to participants and/or parents on background information, health-related quality of life, reports of costs associated with the activity and evaluation will be distributed digitally via e-mail to a secure data capturing system using a unique code for each participant. For COPM, accelerometer and IPAQ data, the physiotherapist will report the results digitally to the secure data capturing system for his/her patient using the unique code for each participant.

The cost- effectiveness will be studied by identifying, measuring, evaluating, and comparing the costs and effects for different interventions. In this project, PAP in people with different disabilities will be compared to a three- month period prior to the PAP intervention started, the participants are their own controls. This means that the comparison option is standard care, which would be the care the participant would have had if/when the intervention was not introduced/started.

Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne.

Data will be collected at 3 months prior to the intervention, just before the intervention starts, when the intervention is finished, and at 6, 12 and 24 months after the intervention.

Ethics:

The study has been reviewed and approved by the Swedish Ethical Review Authority (Dnr 2022-03514-01).

Being tested
Physical activity on prescription
Keywords
Physical activity on prescription, Children, Adolescents, Adults, Individualised intervention, Participation, Health-enhancing physical activity, Disabilities, Physical disability, Intellectual disability, Autism, Cerebral palsy
Medical subject headings
Sedentary Behavior, Cerebral Palsy, Autistic Disorder, Autism Spectrum Disorder, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity on prescriptionBehavioural

    Also called PAP

    Physical activity on prescription (PAP) is a well-established method to enhance physical activity in adults in primary care. The prescribed activity should lead to moderate increase of the pulse, such as walking, cycling, swimming, or gardening, and should be performed over a longer period of time in order to achieve a change towards a more active lifestyle. The activity may be prescribed by a physiotherapist, physician, nurse, or other health professional. PAP has shown to be feasible to increase participation in physical activity and to reduce sedentary behaviour in children with cerebral palsy.

    Motivational interviewing is used for our PAP with participants with disabilities. During PAP-period, the participants are asked to fill in an activity logbook.

Study groups in NCT05867940
Study groupRoleWhat they receive
Children and adolescents with physical disabilitiesActive comparator20 children and adolescents with physical disabilities will participate in physical activity on prescription (PAP). They will be their own controls and will be compared with the other groups. Therefore, there is a baseline 1 and a baseline 2, with 3 months inbetween. After baseline 2, each participant will perform their PAP during 3 months. Assessments to evaluate the results will be performed directly after the 3 months PAP period, and after 6, 12 and 24 months.
Receives: Behavioral: Physical activity on prescription
Children and adolescents with intellectual disabilitiesActive comparator20 children and adolescents with intellectual disabilities will participate in physical activity on prescription (PAP). They will be their own controls and will be compared with the other groups. Therefore, there is a baseline 1 and a baseline 2, with 3 months inbetween. After baseline 2, each participant will perform their PAP during 3 months. Assessments to evaluate the results will be performed directly after the 3 months PAP period, and after 6, 12 and 24 months.
Receives: Behavioral: Physical activity on prescription
Children and adolescents with autismActive comparator20 children and adolescents with autism will participate in physical activity on prescription (PAP). They will be their own controls and will be compared with the other groups. Therefore, there is a baseline 1 and a baseline 2, with 3 months inbetween. After baseline 2, each participant will perform their PAP during 3 months. Assessments to evaluate the results will be performed directly after the 3 months PAP period, and after 6, 12 and 24 months.
Receives: Behavioral: Physical activity on prescription
Adults with physical or intellectual disabilities, or with autismActive comparator20 adults with physical or intellectual disabilities, or with autism will participate in physical activity on prescription (PAP). They will be their own controls and will be compared with the other groups. Therefore, there is a baseline 1 and a baseline 2, with 3 months inbetween. After baseline 2, each participant will perform their PAP during 3 months. Assessments to evaluate the results will be performed directly after the 3 months PAP period, and after 6, 12 and 24 months.
Receives: Behavioral: Physical activity on prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective measurement of physical activity

    Subjective measurement of physical activity by the IPAQ (international physical activity questionnaire). The IPAQ assesses physical activity over the previous week and asks how long and how frequently individuals participate in walking, moderate-intensity activity, and vigorous-intensity activity.

    Measured: 24 months

  2. Objective measurement of physical activity

    Measurement of physical activity measured by an accelerometer. The participants will be asked to wear an accelerometer for 7 days at each assessment (baseline 1 and 2, after the intervention, after 6, 12 and 24 months).

    Measured: 24 months

Secondary outcomes (5)
  1. Measurement of quality of life

    Quality of life measured using the EuroQol Five-Dimensional Questionnaire, Youth Version (EQ-5D-Y) or EuroQol Five-Dimensional Questionnaire, five-level version for adults (EQ-5D-5L)

    Measured: 24 months

  2. Functional goal attainment

    Each participant's goals will be evaluated through the Goal Attainment Scale. The goal/goals are part of the physical activity prescription. The Goal Attainment Scale is described as an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculate the extent to which a patient's goals are met.

    GAS comprises of goals divided into a 5-point scale from -2 to +2.

    Current state, before the intervention starts = -2; Achievement of somewhat less than expected goal = -1; Achievement of goal = 0; Achieved somewhat more than expected outcome = +1; Achievement of much more than expected goal = +2

    Measured: 24 months

  3. Costs for the family

    To analyze the costs of PAP, participants themselves and/or parents will be asked to report direct or indirect costs for the selected activity in a study-specific questionnaire.

    Measured: 24 months

  4. Costs for the physiotherapists

    The physiotherapists will report the amount of hours spent to prepare and carry out the activity as well as evaluate/measure the outcome of the intervention for each participant in a study specific questionnaire.

    Measured: 24 months

  5. Assessment of health care use

    Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start5 Jun 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Four groups of participants will be included in this study; 1) children and adolescents with physical disabilities, 2) children and adolescents with intellectual disabilities, 3) children and adolescents with autism, and 4) adults with physical or intellectual disabilities, or with autism.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05867940
Sponsor's protocol ID
Dnr 2022-03514-01
Acronym
PAP
Status last verified
Nov 2024
First submitted
2 May 2023
Last updated
15 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity on prescription in people with Physical Inactivity and Cerebral Palsy, run by Region Skane 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 8 inclusion and 1 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 15 Nov 2024. 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 Katarina Lauruschkus, PhD (+46 707519888, katarina.lauruschkus@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective measurement of physical activity (time frame: 24 months). 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?
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 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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