NCT04031092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

July 22, 2019

Last Update Submit

January 24, 2020

Conditions

Chronic PainMusculoskeletal Pain

Keywords

ExerciseBiomedical Technology

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • oxygen uptake

    6 weeks (from inclusion to end of rehabilitation program)

  • Anxiety and depression symptoms

    6 weeks (from inclusion to end of rehabilitation program)

  • Average pain

    6 weeks (from inclusion to end of rehabilitation program)

  • Health related quality of life

    6 weeks (from inclusion to end of rehabilitation program)

  • Body weight

    6 weeks (from inclusion to end of rehabilitation program)

  • +1 more secondary outcomes

Study Arms (2)

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.

Device: Wearable tech with feedbackBehavioral: 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.

Device: Wearable tech without feedbackBehavioral: Rehabilitation program

Interventions

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 with feedback
Wearable tech without feedbackDEVICE

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

Wearable tech without feedback
Rehabilitation programBEHAVIORAL

traditional inpatient rehabilitation program.

Wearable tech with feedbackWearable tech without feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unicare Helsefort

Rissa, Norway

Location

MeSH Terms

Conditions

Chronic PainMusculoskeletal PainMotor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lene Aasdahl, PhD MD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Jorunn Helbostad, Dr Philos

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The researchers performing the analyses will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A parallel group design with two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 24, 2019

Study Start

August 8, 2019

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)