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

Primary Purpose

Physical Inactivity, Cerebral Palsy, Autism

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activity on prescription
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Inactivity focused on measuring Physical activity on prescription, Children, Adolescents, Adults, Individualised intervention, Participation, Health-enhancing physical activity, Disabilities, Physical disability, Intellectual disability, Autism, Cerebral palsy

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Meeting the physical activity recommendations

Sites / Locations

  • Department of habilitation, Region Skåne, SwedenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Children and adolescents with physical disabilities

Children and adolescents with intellectual disabilities

Children and adolescents with autism

Adults with physical or intellectual disabilities, or with autism

Arm Description

20 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.

20 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.

20 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.

20 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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)
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
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.
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.
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.

Full Information

First Posted
May 2, 2023
Last Updated
July 27, 2023
Sponsor
Region Skane
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05867940
Brief Title
Effects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities
Acronym
PAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Cerebral Palsy, Autism, Autism Spectrum Disorder, Intellectual Disability, Disability Physical, Sedentary Behavior
Keywords
Physical activity on prescription, Children, Adolescents, Adults, Individualised intervention, Participation, Health-enhancing physical activity, Disabilities, Physical disability, Intellectual disability, Autism, Cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children and adolescents with physical disabilities
Arm Type
Active Comparator
Arm Description
20 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.
Arm Title
Children and adolescents with intellectual disabilities
Arm Type
Active Comparator
Arm Description
20 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.
Arm Title
Children and adolescents with autism
Arm Type
Active Comparator
Arm Description
20 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.
Arm Title
Adults with physical or intellectual disabilities, or with autism
Arm Type
Active Comparator
Arm Description
20 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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity on prescription
Other Intervention Name(s)
PAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective measurement of physical activity
Description
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.
Time Frame
24 months
Title
Objective measurement of physical activity
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Measurement of quality of life
Description
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)
Time Frame
24 months
Title
Functional goal attainment
Description
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
Time Frame
24 months
Title
Costs for the family
Description
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.
Time Frame
24 months
Title
Costs for the physiotherapists
Description
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.
Time Frame
24 months
Title
Assessment of health care use
Description
Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Meeting the physical activity recommendations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Lauruschkus, PhD
Phone
+46 707519888
Email
katarina.lauruschkus@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Annika Lundkvist Josenby, PhD
Phone
+4646178386
Email
annika.lundkvistjosenby@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina Lauruschkus, PhD
Organizational Affiliation
Region Skåne Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of habilitation, Region Skåne, Sweden
City
Malmö
ZIP/Postal Code
21174
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarina Lauruschkus, PhD
Phone
+46707619888
Email
katarina.lauruschkus@skane.se
First Name & Middle Initial & Last Name & Degree
Gisela Teltscher, RPT
Phone
+4641058626
Email
gisela.teltscher@skane.se

12. IPD Sharing Statement

Learn more about this trial

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

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