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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Device: Wearable tech with feedback; Behavioral: Rehabilitation program; Device: Wearable tech without feedback

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Rissa, Norway
    • Unicare Helsefort

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wearable tech without feedback; 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.	Behavioral: Rehabilitation program; traditional inpatient rehabilitation program.; Device: Wearable tech without feedback; An armwrist device measuring physical activity level, no reporting back to the user.
Experimental: Wearable tech with feedback; 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.	Device: Wearable tech with feedback; An armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone.; Behavioral: Rehabilitation program; traditional inpatient rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity level	Time spent in moderate to vigorous physical activity (minutes per day)	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	2 weeks (time period at home between two stays at the rehabilitation center)
Percentage achieving 100 PAIs per week	Personal Activity Intelligence (PAI)	2 weeks (time period at home between two stays at the rehabilitation center)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen uptake	submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)	6 weeks (from inclusion to end of rehabilitation program)
Anxiety and depression symptoms	HSCL-25 questionnaire	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.	6 weeks (from inclusion to end of rehabilitation program)
Health related quality of life	EQ5D questionnaire	6 weeks (from inclusion to end of rehabilitation program)
Body weight	body weight in kilograms	6 weeks (from inclusion to end of rehabilitation program)
Body Mass Index score	weight in kilograms divided by height in metres squared	6 weeks (from inclusion to end of rehabilitation program)

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Lene Aasdahl, PhD MD, National Taiwan Normal University; Study Director: Jorunn Helbostad, Dr Philos, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Biomedical Technology
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: 2019/800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No