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

NCT ID: NCT03434899

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2020-04-16

Brief Summary

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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

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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.

Conditions

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Chronic Widespread Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Health care plan including physical exercise and online support during the entire study

Group Type EXPERIMENTAL

Physical exercise and online support

Intervention Type BEHAVIORAL

Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.

Control Group

Health care plan including physical exercise

Group Type ACTIVE_COMPARATOR

Physical exercise

Intervention Type BEHAVIORAL

Person-centered design of health care plan individually adjusted physical exercise.

Interventions

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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.

Intervention Type BEHAVIORAL

Physical exercise

Person-centered design of health care plan individually adjusted physical exercise.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaisa Mannerkorpi, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgren University Hospital

Locations

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Alingsas Primary Health Care

Alingsås, , Sweden

Site Status

Göteborg Primary Health Care

Gothenburg, , Sweden

Site Status

Uddevalla Primary Health Care

Uddevalla, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 35396312 (View on PubMed)

Other Identifiers

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FOU VGR 237261

Identifier Type: -

Identifier Source: org_study_id

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