NCT02120963

Brief Summary

Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with Rheumatoid Arthritis (RA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2014

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

January 15, 2014

Last Update Submit

August 14, 2018

Conditions

FatigueRheumatoid Arthritis

Keywords

FatigueRheumatoid ArthritisPhysical TherapyPerson-Centred Care

Outcome Measures

Primary Outcomes (1)

  • fatigue

    questionnaire

    6months

Secondary Outcomes (4)

  • Pain during previous week

    6months

  • Physical function

    6months

  • Disease activity

    6 months

  • Health-related quality of life

    6 months

Study Arms (2)

intervention program

EXPERIMENTAL

Person-centered physical therapy intervention program

Behavioral: Person-centered physical therapy intervention program

Control group

NO INTERVENTION

Health care as usual

Interventions

Person-centered physical therapy intervention programBEHAVIORAL

Comparison of person-centered physical therapy and control group

intervention program

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aging 20-65 years, disease duration \>3 year, stable pharmacological treatment

You may not qualify if:

  • Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

rheumatology clinic at Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

FatigueArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kaisa Mannerkorpi, Ass prof

    Göteborg University, Dept of Rheumatology

    PRINCIPAL INVESTIGATOR

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

January 15, 2014

First Posted

April 23, 2014

Study Start

November 1, 2013

Primary Completion

October 10, 2014

Study Completion

October 10, 2014

Last Updated

August 15, 2018

Record last verified: 2018-08

Locations

SE(1)