Back to resultsEffects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP) (GAU-E)
Primary Purpose
Chronic Widespread Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical exercise and online support
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Widespread Pain
Eligibility Criteria
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
Sites / Locations
- Alingsas Primary Health Care
- Göteborg Primary Health Care
- Uddevalla Primary Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control Group
Arm Description
Health care plan including physical exercise and online support during the entire study
Health care plan including physical exercise
Outcomes
Primary Outcome Measures
Pain during the last week
The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.
Secondary Outcome Measures
Fatigue
The Multidimensional Fatigue Inventory (MFI-20), comprising several subscale, of which the Physical Fatigue subscale is of interest for this study.
Health
The Fibromyalgia Impact Questionnaire (FIQ) total score. The FIQ comprises 10 subscales and the total score is the mean value of them.
Full Information
NCT ID
NCT03434899
First Posted
February 6, 2018
Last Updated
October 5, 2020
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden, Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT03434899
Brief Title
Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
Acronym
GAU-E
Official Title
Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden, Vastra Gotaland Region
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Widespread Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Health care plan including physical exercise and online support during the entire study
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Health care plan including physical exercise
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise and online support
Intervention Description
Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
Person-centered design of health care plan individually adjusted physical exercise.
Primary Outcome Measure Information:
Title
Pain during the last week
Description
The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.
Time Frame
Change from Baseline Pain at 6 months
Secondary Outcome Measure Information:
Title
Fatigue
Description
The Multidimensional Fatigue Inventory (MFI-20), comprising several subscale, of which the Physical Fatigue subscale is of interest for this study.
Time Frame
Change from Baseline Fatigue at 6 months
Title
Health
Description
The Fibromyalgia Impact Questionnaire (FIQ) total score. The FIQ comprises 10 subscales and the total score is the mean value of them.
Time Frame
Change from Baseline Health at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa Mannerkorpi, PhD
Organizational Affiliation
Sahlgren University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alingsas Primary Health Care
City
Alingsas
Country
Sweden
Facility Name
Göteborg Primary Health Care
City
Göteborg
Country
Sweden
Facility Name
Uddevalla Primary Health Care
City
Uddevalla
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35396312
Citation
Feldthusen C, Bergenheim A, Barenfeld E, Gjertsson I, Larsson A, Mannerkorpi K. Experience of co-creation of a health plan and support for sustainable physical activity among people with chronic widespread pain: a qualitative interview study in Sweden. BMJ Open. 2022 Apr 8;12(4):e059432. doi: 10.1136/bmjopen-2021-059432.
Results Reference
derived
Learn more about this trial
Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
We'll reach out to this number within 24 hrs