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

NCT05867940 | Recruiting

• 1 other identifier: Dnr 2022-03514-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months

• 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).

  24 months

Secondary Outcomes (5)

• Measurement of quality of life

  24 months

• Functional goal attainment

  24 months

• Costs for the family

  24 months

• Costs for the physiotherapists

  24 months

• Assessment of health care use

  24 months

Study Arms (4)

Children and adolescents with physical disabilities

ACTIVE COMPARATOR

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.

Behavioral: Physical activity on prescription

Children and adolescents with intellectual disabilities

ACTIVE COMPARATOR

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.

Behavioral: Physical activity on prescription

Children and adolescents with autism

ACTIVE COMPARATOR

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.

Behavioral: Physical activity on prescription

Adults with physical or intellectual disabilities, or with autism

ACTIVE COMPARATOR

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.

Behavioral: Physical activity on prescription

Interventions

Physical activity on prescription BEHAVIORAL

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.

Also known as: PAP

Adults with physical or intellectual disabilities, or with autism; Children and adolescents with autism; Children and adolescents with intellectual disabilities; Children and adolescents with physical disabilities

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Meeting the physical activity recommendations

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Department of habilitation, Region Skåne, Sweden

Malmo, 21174, Sweden

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Cerebral Palsy; Autistic Disorder; Autism Spectrum Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Behavior; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarina Lauruschkus, PhD

  Region Skåne Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarina Lauruschkus, PhD

CONTACT

+46 707519888; katarina.lauruschkus@med.lu.se

Annika Lundkvist Josenby, PhD

CONTACT

+4646178386; annika.lundkvistjosenby@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 22, 2023
• Study Start: June 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

SE (1)