Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

Rheumatoid Arthritis Clinical Trial

— RAFatigueRCT  

Official title:

The Effect of Person-centered Physical Therapy on Fatigue Related Variables in Persons With Rheumatoid Arthritis- Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120963
• Other study ID #: FatigueRA-RCT
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: October 10, 2014

Study information

• Verified date: August 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The effect of person-centered physical therapy on fatigue related variables in peoples with Rheumatoid Arthritis- Randomized controlled trial Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with RA.

Hypothesis: That the person-centered treatment program diminishes fatigue and its consequences on daily life.

Design: A controlled randomized interventional trial, assessing effectiveness of intervention.

Methods:

Selection: Seventy persons with diagnosis of RA and fatigue over 50 (0-100) will be recruited from the rheumatology clinic at Sahlgrenska University Hospital. Participants are randomized to an intervention group or a waiting list control group.

Intervention: The 12-week intervention period begins with an individual person-centered meeting to develop an individualized feasible self-care plan for the participant with extra focus on health-enhancing physical activity, stress management (relaxation exercise training and modified mindfulness techniques) and balance in daily life. A written consent, aiming to increase coherence, is signed. The participants will be asked to keep a journal about their strategies and reflections. Follow up meetings and contacts will be planned according to personal preferences.

Procedure: The participants are invited to a clinical examination before and after the 12-week intervention and at 6-month follow-up, assessing demographic data, disease activity, inflammation parameters, physical capacity and questionnaires of health status in RA. Primary outcome are questionnaires of single item- and multidimensional fatigue.

Analysis: Effects of the interventions will be analyzed using non-parametric statistics for between-group changes over time. Within-group changes over time will be analyzed for each group.

Expected results. New knowledge of fatigue is of importance for improvement of overall health of people with RA, as fatigue influences all aspects of their life, both private life and employment, thus decreasing the quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 10, 2014
• Est. primary completion date: October 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fatigue
• Rheumatoid Arthritis

Intervention

Behavioral:
• Person-centered physical therapy intervention program
Comparison of person-centered physical therapy and control group

Locations

Country	Name	City	State
Sweden	rheumatology clinic at Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgren´s University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue	questionnaire	6months
Secondary	Pain during previous week	VAS	6months
Secondary	Physical function	Performance based test	6months
Secondary	Disease activity	DAS-28	6 months
Secondary	Health-related quality of life	Questionnaire	6 months