Intellectual DisabilityPA-IDeNCT04079439
Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability
A study testing Physical activity with tailored e-health support in people with Intellectual Disability, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Physical activity with tailored e-health support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Intellectual disability
- Age 15-60 years
- Low physical activity
- Sedentary lifestyle
Who cannot join
- Medical contradictions for participation
- High levels of physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability (PA-IDe Study): a Randomised Controlled Trial
The main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.
Read the detailed description
Individuals with intellectual disability (ID) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. As increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. E-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with ID.
The purpose of this study is to examine the effectiveness of an individually tailored PA programme with motivational mobile e-health support on everyday level of PA in youths and adults with ID.
The PA-IDE trial uses a prospective randomized controlled design. In total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. The intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. The intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. Participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). All participants will be assessed at baseline, 3-, and 6 months. Participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the Goal Attainment Scaling (GAS) will be used. Primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. Secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a PA setting, behaviour problems, and goal attainment.
The investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. Technology offers new opportunities to influence healthy behaviours. The trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with ID.
- Conditions
- Intellectual Disability
- Being tested
- Physical activity with tailored e-health support
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity with tailored e-health supportBehavioural
Also called Activity planner
The planned e-health intervention will contain several elements: A motivating smartphone app registers indoor- and outdoor activity as well as activity from the use of an ergometer-bike. For recording of outdoor activity commercial wrist-born accelerometers will be used. The app-solution will be motivating and result in a reward after a predefined level of activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Tailored e-heath support for physical activity with a focus on communication and rewards, using commercial accelerometers for measurements Receives: Behavioral: Physical activity with tailored e-health support |
| Control group | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day
The primary outcome is physical activity, objectively assessed by steps per day measured with an accelerometer. This will objectively assess physical activity and sedentary time. Change in steps per day is being assessed at baseline, after three months of intervention and after 6 months of intervention.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (10)
Physical activity
The International Physical Activity Questionnaire - Short Form, adapted to measure PA using proxy respondents (IPAQ-SF) will be used. The IPAQ-SF is a 7-item questionnaire that assesses PA the last seven days at four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.
Measured: Baseline, 3 months and 6 months
Blood pressure
The blood pressure will be measured in units of millimeters of mercury (mmHg) using Welsh-Allyn device. Both systolic blood pressure and diastolic blood pressure will be measured.
Measured: Baseline, 3 months and 6 months
Waist Circumference
Waist circumference will be measured in cm. Measurements will be done 1 cm above the navel.
Measured: Baseline, 3 months and 6 months
Body Mass Index (BMI)
Height will be measured with a stadiometer (Seca) in meters, with the participant wearing no shoes. Weight measured with an analog, floor scale (Seca) in kilograms, with participants wearing no shoes or outdoors jacket/gears. For participants in wheelchair or with difficulty standing on a small plate a wheelchair weight (Seca) will be used. Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline, 3 months and 6 months
Physical functioning
The Short Physical Performance Battery (SPPB) will used to assess physical functioning. The SPPB is a screening test designed to assess physical performance and predict disability in older population. The SPPB is mainly a measure of lower-extremity function and consists of three subtests; 1) Static balance: Standing balance is tested with the feet in the side-by-side, semi tandem and tandem positions for 10 s each; 2) Gait speed: a 4 meter (13ft) walk at the individual´s habitual pace.; 3) Lower limb strength as indicated by the ability to rise from a chair with folded arms across their chest.
Measured: Baseline, 3 months and 6 months
Self-efficacy and social support
The Self-Efficacy/Social Support scales for Activity for persons with Intellectual Disability (SE/SS-AID) is a questionnaire consisting of four scales, where one scale measure self-efficacy for overcoming barriers to leisure PA. The last three scales measure social support for leisure activity from family members, residential staff, and friends with ID. The scale is validated for self-reporting from individuals with mild to moderate intellectual disability or can be used by proxy respondents. The questionnaire will be translated into the Norwegian language using standard guidelines.
Measured: Baseline, 3 months and 6 months
Challenging behaviour
The Aberrant Behavior Checklist-Community (ABC-C) is a questionnaire designed to assess challenging behavior in children, youths and adults with an intellectual disability. The ABC is a 58-item checklist grouped into five subscales. It is a proxy measure requiring knowledge of the index person. Assigned weighted scores 0-3 (3 indicating most severe), grouped into five symptom-clusters (irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech). The questionnaire has been validated for use in a Norwegian population with neurodevelopmental disabilities.
Measured: Baseline, 3 months and 6 months
Satisfaction with life
Satisfaction of life is a scale developed by Bergström, Hochwälder, Kottorp, and Elinder (2013) for assessing satisfaction with home environment and leisure time among individuals with mild to moderate ID. The outcome is measured by four factors: 1) satisfaction with housing environment; 2) satisfaction with life; 3) satisfaction with meals; and 4) satisfaction with recreational activities. Items are read out load by a researcher and answered by 'good' (happy face = 2), 'in between' (neutral face = 1) and 'bad' (sad face = 0). In the current study the scale is used to control for adverse effects.
Measured: Baseline, 3 months and 6 months
Social network
The Social Support scales for Activity for persons with Intellectual Disability (SS-AID) is a 17-item scale for measuring social support from family, paid staff and roommates with disabilities. The scale is self-report and validated for individuals with mild to moderate intellectual disability.
Measured: Baseline, 3 months and 6 months
Goalsetting
The Goal attainment scale (GAS) will be used to identify self-management goals that participants want to achieve. The questionnaire will be filled out by the researcher, with participants and proxy respondents present. Completing the GAS involves several steps. Goals are selected by each individual and observable behavior that reflects a degree of goal attainment is defined. The participant's pre-treatment or baseline levels is defined in respect to the goal. Five different goal attainment levels are defined, ranging from "no change" to "much better than expected outcome" (numbered -2 to +2). Follow-up times for participant evaluation are set (presumably after 3- and 6 months). Participants are evaluated after the defined time interval. At the end, the overall attainment score for all goals are calculated. In this study we will define up to three goals for PA.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2020
- Primary completion1 May 2020
- Study completion1 Jan 2022
Why it stopped: Because of COVID-19 the study was stopped. It has been changed to include a pilot trial, which has been conducted in 2021/2022 (trial registration: NCT04929106). The RCT will hopefully be conducted in the near future.
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 Intellectual DisabilityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed randomised controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Audny Anke, Professor, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079439
- Sponsor's protocol ID
- HNF1353-17
- Acronym
- PA-IDe
- Status last verified
- Jun 2021
- First submitted
- 20 Aug 2019
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A study protocol article will be published
Publications
Michalsen H, Wangberg SC, Hartvigsen G, Jaccheri L, Muzny M, Henriksen A, Olsen MI, Thrane G, Jahnsen RB, Pettersen G, Arntzen C, Anke A. Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 29;9(6):e19213. doi: 10.2196/19213.
PubMed 32437328
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity With Tailored E-health Support for Individuals With Intellectual Disability (PA-IDe Study): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04079439
- Acronym / sponsor ID
- PA-IDe / HNF1353-17
- Conditions
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of COVID-19 the study was stopped. It has been changed to include a pilot trial, which has been conducted in 2021/2022 (trial registration: NCT04929106). The RCT will hopefully be conducted in the near future.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 6 Sep 2019 (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 main objective of this project is to enhance physical activity in youths and adults with intellectual disabilities (IDs) by developing and testing a tailored e-heath support for motivation and participation in physical activity.
Detailed description
Individuals with intellectual disability (ID) have lower levels of physical activity and greater barriers for participation in fitness activities, compared to the general population. As increased physical activity has positive effects on cardiovascular and psychosocial health, identifying effective interventions for use in everyday settings is exceedingly important. E-health like motion sensor games (exergames) and smartphone reminders for physical activity have been explored and found to be promising in people with ID.
The purpose of this study is to examine the effectiveness of an individually tailored PA programme with motivational mobile e-health support on everyday level of PA in youths and adults with ID.
The PA-IDE trial uses a prospective randomized controlled design. In total, 60 participants with a sedentary lifestyle or low physical activity level will be included, aging from 16-60 years old. The intervention consists of a tailored e-health support intervention, using smartphones or tablets to create structure and predictability of physical activities. The intervention emphasizes the communicative abilities of individual participants and use rewards and give feedback of progress to motivate individuals to increase participation in physical activity. Participants will be allocated to groups consisting of 30 participants who receive either the e-health intervention or standard care (control). All participants will be assessed at baseline, 3-, and 6 months. Participants in the intervention group, close relatives or care staff will be invited to participate in a goal-setting meeting about physical activity in the intervention period, where the Goal Attainment Scaling (GAS) will be used. Primary outcome will be physical activity level measured as steps per day with commercial wrist-worn accelerometers. Secondary outcome measures include minutes of moderate activity, energy expenditure, social support for physical activity, self-efficacy in a PA setting, behaviour problems, and goal attainment.
The investigators expect that the new intervention will perform better than standard care in terms of improved physical activity, mastery, and social support for activities. Technology offers new opportunities to influence healthy behaviours. The trial results will determine the effectiveness and sustainability of a tailored e-health support intervention to increase physical activity among youths and adults with ID.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-armed randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Physical activity with tailored e-health supportTailored e-heath support for physical activity with a focus on communication and rewards, using commercial accelerometers for measurements |
| Control group | No intervention | –Standard care |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Intellectual disability
- Age 15-60 years
- Low physical activity
- Sedentary lifestyle
Key exclusion criteria (2 listed)
- Medical contradictions for participation
- High levels of physical activity
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 |
|---|---|---|
| Physical activity with tailored e-health supportAlso: Activity plannerThe planned e-health intervention will contain several elements: A motivating smartphone app registers indoor- and outdoor activity as well as activity from the use of an ergometer-bike. For recording of outdoor activity commercial wrist-born accelerometers will be used. The app-solution will be motivating and result in a reward after a predefined level of activity. | Behavioural | Intervention |
Primary outcome
Steps per day
Time frame: Baseline, 3 months and 6 months
The primary outcome is physical activity, objectively assessed by steps per day measured with an accelerometer. This will objectively assess physical activity and sedentary time. Change in steps per day is being assessed at baseline, after three months of intervention and after 6 months of intervention.
10 secondary outcomes
Physical activity
Time frame: Baseline, 3 months and 6 months
Blood pressure
Time frame: Baseline, 3 months and 6 months
Waist Circumference
Time frame: Baseline, 3 months and 6 months
Body Mass Index (BMI)
Time frame: Baseline, 3 months and 6 months
Physical functioning
Time frame: Baseline, 3 months and 6 months
Self-efficacy and social support
Time frame: Baseline, 3 months and 6 months
Challenging behaviour
Time frame: Baseline, 3 months and 6 months
Satisfaction with life
Time frame: Baseline, 3 months and 6 months
Social network
Time frame: Baseline, 3 months and 6 months
Goalsetting
Time frame: Baseline, 3 months and 6 months
Results and safety
The study was stopped early (reason given: Because of COVID-19 the study was stopped. It has been changed to include a pilot trial, which has been conducted in 2021/2022 (trial registration: NCT04929106). The RCT will hopefully be conducted in the near future.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 32437328Michalsen H, Wangberg SC, Hartvigsen G, Jaccheri L, Muzny M, Henriksen A, Olsen MI, Thrane G, Jahnsen RB, Pettersen G, Arntzen C, Anke A. Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 29;9(6):e19213. doi: 10.2196/19213.
- Individual participant dataSharing planned: Yes. A study protocol article will be published
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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. This study is not recruiting at the moment.
Audny Anke, Professor principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity with tailored e-health support in people with Intellectual Disability, run by University Hospital of North Norway at 1 site in Norway.
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 4 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: stopped early, as of the sponsor's last update on 10 Jan 2023. 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 Norway. 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?
The study was stopped early (reason given: Because of COVID-19 the study was stopped. It has been changed to include a pilot trial, which has been conducted in 2021/2022 (trial registration: NCT04929106). The RCT will hopefully be conducted in the near future.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps per day (time frame: Baseline, 3 months and 6 months). 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 NCT04079439, 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 10 Jan 2023.