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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031092
• Other study ID #: 2019/800
• Status: Completed
• Phase: N/A
• Start date: August 8, 2019
• Est. completion date: January 14, 2020

Study information

• Verified date: January 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 14, 2020
• Est. primary completion date: January 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

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.
• Wearable tech without feedback
An armwrist device measuring physical activity level, no reporting back to the user.

Behavioral:
• Rehabilitation program
traditional inpatient rehabilitation program.

Locations

Country	Name	City	State
Norway	Unicare Helsefort	Rissa

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Percentage achieving 100 PAIs per week	Personal Activity Intelligence (PAI)	2 weeks (time period at home between two stays at the rehabilitation center)
Secondary	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)
Secondary	Anxiety and depression symptoms	HSCL-25 questionnaire	6 weeks (from inclusion to end of rehabilitation program)
Secondary	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)
Secondary	Health related quality of life	EQ5D questionnaire	6 weeks (from inclusion to end of rehabilitation program)
Secondary	Body weight	body weight in kilograms	6 weeks (from inclusion to end of rehabilitation program)
Secondary	Body Mass Index score	weight in kilograms divided by height in metres squared	6 weeks (from inclusion to end of rehabilitation program)