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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorRegion Skane

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physical inactivity

Not meeting the physical activity recommendations

Much sedentary time

Physical disability

Disqualifiers

Meeting the physical activity recommendations

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Children and adolescents with physical disabilitiesActive comparator 1 intervention
Group B: Children and adolescents with intellectual disabilitiesActive comparator 1 intervention
Group C: Children and adolescents with autismActive comparator 1 intervention
Group D: Adults with physical or intellectual disabilities, or with autismActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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).

Time frame
24 months

Secondary outcomes

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)

Time frame
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

Time frame
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.

Time frame
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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Lund University

Collaborator