Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02120963
Study type	Interventional
Source	Göteborg University
Contact
Status	Completed
Phase	N/A
Start date	November 2013
Completion date	October 10, 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04226131` - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics	N/A
Completed	`NCT04171414` - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis	Phase 3
Completed	`NCT02833350` - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)	Phase 2
Completed	`NCT04255134` - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Phase 4
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed	`NCT03248518` - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases	N/A
Completed	`NCT03514355` - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms	N/A
Recruiting	`NCT06005220` - SBD121, a Synbiotic Medical Food for RA Management	N/A
Recruiting	`NCT05451615` - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis	Phase 3
Completed	`NCT05054920` - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT02037737` - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting	N/A
Recruiting	`NCT04079374` - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel	Phase 3
Completed	`NCT02504268` - Effects of Abatacept in Patients With Early Rheumatoid Arthritis	Phase 3
Recruiting	`NCT05496855` - Remote Care in People With Rheumatoid Arthritis	N/A
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06031415` - Study of GS-0272 in Participants With Rheumatoid Arthritis	Phase 1
Recruiting	`NCT06103773` - A Study of Single and Multiple Oral Doses of TollB-001	Phase 1
Completed	`NCT05999266` - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting	`NCT05302934` - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting	`NCT04169100` - Novel Form of Acquired Long QT Syndrome	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial — RAFatigueRCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms