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

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Wearable tech with feedback
Wearable tech without feedback
Rehabilitation program
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Exercise, Biomedical Technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Unicare Helsefort

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wearable tech with feedback

Wearable tech without feedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Activity level
Time spent in moderate to vigorous physical activity (minutes per day)
Number of PAIs
mean number of Personal Activity Intelligence (PAI) points achieved per week
Percentage achieving 100 PAIs per week
Personal Activity Intelligence (PAI)

Secondary Outcome Measures

oxygen uptake
submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
Anxiety and depression symptoms
HSCL-25 questionnaire
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.
Health related quality of life
EQ5D questionnaire
Body weight
body weight in kilograms
Body Mass Index score
weight in kilograms divided by height in metres squared

Full Information

First Posted
July 22, 2019
Last Updated
January 24, 2020
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04031092
Brief Title
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
Official Title
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
January 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain
Keywords
Exercise, Biomedical Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel group design with two groups
Masking
Investigator
Masking Description
The researchers performing the analyses will be blinded
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable tech with feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Wearable tech without feedback
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wearable tech with feedback
Intervention Description
An armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone.
Intervention Type
Device
Intervention Name(s)
Wearable tech without feedback
Intervention Description
An armwrist device measuring physical activity level, no reporting back to the user.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation program
Intervention Description
traditional inpatient rehabilitation program.
Primary Outcome Measure Information:
Title
Activity level
Description
Time spent in moderate to vigorous physical activity (minutes per day)
Time Frame
2 weeks (time period at home between two stays at the rehabilitation center)
Title
Number of PAIs
Description
mean number of Personal Activity Intelligence (PAI) points achieved per week
Time Frame
2 weeks (time period at home between two stays at the rehabilitation center)
Title
Percentage achieving 100 PAIs per week
Description
Personal Activity Intelligence (PAI)
Time Frame
2 weeks (time period at home between two stays at the rehabilitation center)
Secondary Outcome Measure Information:
Title
oxygen uptake
Description
submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
Time Frame
6 weeks (from inclusion to end of rehabilitation program)
Title
Anxiety and depression symptoms
Description
HSCL-25 questionnaire
Time Frame
6 weeks (from inclusion to end of rehabilitation program)
Title
Average pain
Description
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.
Time Frame
6 weeks (from inclusion to end of rehabilitation program)
Title
Health related quality of life
Description
EQ5D questionnaire
Time Frame
6 weeks (from inclusion to end of rehabilitation program)
Title
Body weight
Description
body weight in kilograms
Time Frame
6 weeks (from inclusion to end of rehabilitation program)
Title
Body Mass Index score
Description
weight in kilograms divided by height in metres squared
Time Frame
6 weeks (from inclusion to end of rehabilitation program)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Aasdahl, PhD MD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorunn Helbostad, Dr Philos
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Unicare Helsefort
City
Rissa
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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