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Completed

NCT Number: NCT04031092

Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain

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.

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Key information

Conditions

Chronic Pain Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unicare Helsefort

Rissa, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.

Exclusion criteria

  • 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)

Treatment and study plan

Wearable tech with feedback

Device

An armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone.

Wearable tech without feedback

Device

An armwrist device measuring physical activity level, no reporting back to the user.

Rehabilitation program

Behavioral

traditional inpatient rehabilitation program.

Primary outcomes

  1. 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)

  2. 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

  3. 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)

Secondary outcomes

  1. oxygen uptake

    Time frame: 6 weeks (from inclusion to end of rehabilitation program)

    submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)

  2. Anxiety and depression symptoms

    Time frame: 6 weeks (from inclusion to end of rehabilitation program)

    HSCL-25 questionnaire

  3. Average pain

    Time frame: 6 weeks (from inclusion to end of rehabilitation program)

    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.

  4. Health related quality of life

    Time frame: 6 weeks (from inclusion to end of rehabilitation program)

    EQ5D questionnaire

  5. Body weight

    Time frame: 6 weeks (from inclusion to end of rehabilitation program)

    body weight in kilograms

  6. Body Mass Index score

    Time frame: 6 weeks (from inclusion to end of rehabilitation program)

    weight in kilograms divided by height in metres squared

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2019
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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