Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP) (GAU-E)

October 5, 2020 updated by: Göteborg University
The aim is to evaluate a novel treatment routine where contact through a smart phone/computer is used for online support for patients suffering from chronic widespread pain (CWP). The outline is that patients are encouraged to perform physical activity during a period of 12 months with online support from a physical therapist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention follows principles from the theories of person-centered care and self-efficacy. The examinations performed at baseline and after six months were conducted by blinded examiners at a visit at the primary health care centers. All participants developed a person-centered health plan for physical activity together with a physiotherapist. The intervention group was supported with a digital platform for six months.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alingsas, Sweden
        • Alingsas Primary Health Care
      • Göteborg, Sweden
        • Göteborg Primary Health Care
      • Uddevalla, Sweden
        • Uddevalla Primary Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
  • access to a smart phone or computer

Exclusion Criteria:

  • other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
  • unable to speak or read Swedish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Health care plan including physical exercise and online support during the entire study
Behavioral: Physical exercise and online support
Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.
Active Comparator: Control Group
Health care plan including physical exercise
Behavioral: Physical exercise
Person-centered design of health care plan individually adjusted physical exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during the last week
Time Frame: Change from Baseline Pain at 6 months
The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.
Change from Baseline Pain at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Change from Baseline Fatigue at 6 months
The Multidimensional Fatigue Inventory (MFI-20), comprising several subscale, of which the Physical Fatigue subscale is of interest for this study.
Change from Baseline Fatigue at 6 months
Health
Time Frame: Change from Baseline Health at 6 months
The Fibromyalgia Impact Questionnaire (FIQ) total score. The FIQ comprises 10 subscales and the total score is the mean value of them.
Change from Baseline Health at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Vastra Gotaland Region
Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Kaisa Mannerkorpi, PhD, Sahlgren University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 16, 2020

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOU VGR 237261

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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