Chronic PainNCT04031092
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
A study testing Wearable tech with feedback, Wearable tech without feedback and Rehabilitation program in people with Chronic Pain and Musculoskeletal Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this project is to evaluate whether use of wearable tech increases levels of physical activity in patients participating in inpatient rehabilitation for chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Wearable tech with feedback, Wearable tech without feedback and Rehabilitation program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNorway
- Study dates
- 8 Aug 2019to 14 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.
Who cannot join
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this project is to evaluate whether use of wearable tech increases levels of physical activity in patients participating in inpatient rehabilitation for chronic pain.
Read the detailed description
Chronic pain is a vast problem with profound consequences for individuals and societies. Exercise and physical activity is an important part of the treatment for chronic pain. Use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. Here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.
The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for personal activity Intelligence. You earn PAI points every time your heart rate increases: The higher heart rate, the faster you earn PAI. Previous research have shown that those who achieve 100 PAI or more every week over time live for an average of more than eight years longer than others.
During the study all participants will take part in a traditional inpatient rehabilitation program. The program consist of two periods at the rehabilitation center with two weeks at home in-between. The study will take place during the two periods at the senter and the period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Being tested
- Wearable tech with feedback, Wearable tech without feedback, Rehabilitation program
- Keywords
- Exercise, Biomedical Technology
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable tech with feedbackDevice
An armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone.
Wearable tech without feedbackDevice
An armwrist device measuring physical activity level, no reporting back to the user.
Rehabilitation programBehavioural
traditional inpatient rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Wearable tech with feedback | Experimental | This group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for patients with chronic pain. Receives: Device: Wearable tech with feedback; Behavioral: Rehabilitation program |
| Wearable tech without feedback | Active comparator | This group will be wearing the same the activity measurement device as the intervention group, but they will not receive any feedback about their activity level. They will not have access to the mobile application. They will take part in the same rehabilitation program as the intervention group. Receives: Device: Wearable tech without feedback; Behavioral: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity level
Time spent in moderate to vigorous physical activity (minutes per day)
Measured: 2 weeks (time period at home between two stays at the rehabilitation center)
Number of PAIs
mean number of Personal Activity Intelligence (PAI) points achieved per week
Measured: 2 weeks (time period at home between two stays at the rehabilitation center)
Percentage achieving 100 PAIs per week
Personal Activity Intelligence (PAI)
Measured: 2 weeks (time period at home between two stays at the rehabilitation center)
Secondary outcomes (6)
oxygen uptake
submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
Measured: 6 weeks (from inclusion to end of rehabilitation program)
Anxiety and depression symptoms
HSCL-25 questionnaire
Measured: 6 weeks (from inclusion to end of rehabilitation program)
Average pain
Visual Analogue Scale (VAS). VAS is a straight horizontal line where the ends are defined as the extreme limits from the left (0-no pain) to the right (100-worst imaginable pain). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
Measured: 6 weeks (from inclusion to end of rehabilitation program)
Health related quality of life
EQ5D questionnaire
Measured: 6 weeks (from inclusion to end of rehabilitation program)
Body weight
body weight in kilograms
Measured: 6 weeks (from inclusion to end of rehabilitation program)
Body Mass Index score
weight in kilograms divided by height in metres squared
Measured: 6 weeks (from inclusion to end of rehabilitation program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start8 Aug 2019
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group design with two groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Aasdahl, PhD MD, Principal investigator, National Taiwan Normal UniversityJorunn Helbostad, Dr Philos, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031092
- Sponsor's protocol ID
- 2019/800
- Status last verified
- Jan 2020
- First submitted
- 22 Jul 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT04031092
- Acronym / sponsor ID
- 2019/800
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- Exercise, Biomedical Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 24 Jul 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 aim of this project is to evaluate whether use of wearable tech increases levels of physical activity in patients participating in inpatient rehabilitation for chronic pain.
Detailed description
Chronic pain is a vast problem with profound consequences for individuals and societies. Exercise and physical activity is an important part of the treatment for chronic pain. Use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. Here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.
The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for personal activity Intelligence. You earn PAI points every time your heart rate increases: The higher heart rate, the faster you earn PAI. Previous research have shown that those who achieve 100 PAI or more every week over time live for an average of more than eight years longer than others.
During the study all participants will take part in a traditional inpatient rehabilitation program. The program consist of two periods at the rehabilitation center with two weeks at home in-between. The study will take place during the two periods at the senter and the period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A parallel group design with two groups
| Arm | Type | Receives |
|---|---|---|
| Wearable tech with feedback | Experimental | Device: Wearable tech with feedback, Behavioral: Rehabilitation programThis group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for patients with chronic pain. |
| Wearable tech without feedback | Active comparator | Device: Wearable tech without feedback, Behavioral: Rehabilitation programThis group will be wearing the same the activity measurement device as the intervention group, but they will not receive any feedback about their activity level. They will not have access to the mobile application. They will take part in the same rehabilitation program as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.
Key exclusion criteria (2 listed)
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
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 |
|---|---|---|
| Wearable tech with feedbackAn armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone. | Device | Wearable tech with feedback |
| Wearable tech without feedbackAn armwrist device measuring physical activity level, no reporting back to the user. | Device | Wearable tech without feedback |
| Rehabilitation programtraditional inpatient rehabilitation program. | Behavioural | Wearable tech with feedback, Wearable tech without feedback |
Primary outcome
Activity level
Time frame: 2 weeks (time period at home between two stays at the rehabilitation center)
Time spent in moderate to vigorous physical activity (minutes per day)
Number of PAIs
Time frame: 2 weeks (time period at home between two stays at the rehabilitation center)
mean number of Personal Activity Intelligence (PAI) points achieved per week
Percentage achieving 100 PAIs per week
Time frame: 2 weeks (time period at home between two stays at the rehabilitation center)
Personal Activity Intelligence (PAI)
6 secondary outcomes
oxygen uptake
Time frame: 6 weeks (from inclusion to end of rehabilitation program)
Anxiety and depression symptoms
Time frame: 6 weeks (from inclusion to end of rehabilitation program)
Average pain
Time frame: 6 weeks (from inclusion to end of rehabilitation program)
Health related quality of life
Time frame: 6 weeks (from inclusion to end of rehabilitation program)
Body weight
Time frame: 6 weeks (from inclusion to end of rehabilitation program)
Body Mass Index score
Time frame: 6 weeks (from inclusion to end of rehabilitation program)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Lene Aasdahl, PhD MD principal investigator
National Taiwan Normal University
Jorunn Helbostad, Dr Philos study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable tech with feedback, Wearable tech without feedback and Rehabilitation program in people with Chronic Pain and Musculoskeletal Pain, run by Norwegian University of Science and Technology 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 1 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: finished, as of the sponsor's last update on 27 Jan 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Activity level (time frame: 2 weeks (time period at home between two stays at the rehabilitation center)). The study lists 3 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 27 Jan 2020.