Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
GAU-E
1 other identifier
interventional
139
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedStudy Start
First participant enrolled
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2020
CompletedOctober 8, 2020
October 1, 2020
1.1 years
February 6, 2018
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pain during the last week
The Fibromyalgia Impact Questionnaire (FIQ) subscale for pain.
Change from Baseline Pain at 6 months
Secondary Outcomes (2)
Fatigue
Change from Baseline Fatigue at 6 months
Health
Change from Baseline Health at 6 months
Study Arms (2)
Intervention group
EXPERIMENTALHealth care plan including physical exercise and online support during the entire study
Control Group
ACTIVE COMPARATORHealth care plan including physical exercise
Interventions
Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.
Person-centered design of health care plan individually adjusted physical exercise.
Eligibility Criteria
You may qualify if:
- fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
- access to a smart phone or computer
You may not qualify if:
- other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
- unable to speak or read Swedish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Sahlgrenska University Hospitalcollaborator
- Vastra Gotaland Regioncollaborator
Study Sites (3)
Alingsas Primary Health Care
Alingsås, Sweden
Göteborg Primary Health Care
Gothenburg, Sweden
Uddevalla Primary Health Care
Uddevalla, Sweden
Related Publications (1)
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.
PMID: 35396312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaisa Mannerkorpi, PhD
Sahlgren University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2018
First Posted
February 15, 2018
Study Start
February 15, 2018
Primary Completion
April 1, 2019
Study Completion
April 16, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share