Clinical trial NCT05759585: Examining the Efficacy of Personalized Lifestyle Intervention in Individuals With Rheumatoid Arthritis
Official title: Examining the Effects of Person-centered Lifestyle Intervention in Individuals With Rheumatoid Arthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Arthritis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis.

Detailed description: Rheumatoid arthritis (RA) is defined as a chronic, inflammatory autoimmune disease that can damage both joints and non-articular organs, including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system.

Management of RA requires a multidisciplinary approach, as common risk factors for RA include both modifiable lifestyle-related variables and non-modifiable traits such as genetics and gender. Although there is no definitive cure, it is necessary to optimize physical, emotional, and social health in order to minimize the impact of the disease. At this point, self-management interventions come to the fore.

Since many areas of life are affected in individuals with RA, it is seen that there is a need for combined treatments that address the individual holistically, as suggested by EULAR. Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. There is strong evidence in the literature that Lifestyle intervention is an effective approach to managing the symptoms of many chronic diseases.

The number of studies involving lifestyle interventions in individuals with RA, whose importance is emphasized in the literature, is limited. Therefore, our study was planned to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with RA. Hypotheses:

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with RA between the ages of 18-65 and meeting the ACR/EULAR diagnostic criteria
* Patients with low to moderate disease activity (DAS28 ≤5.1)
* No pharmacological treatment changes for RA in the last 3 months
* Have not had any surgery in the last 6 months
* Understand and cooperate with testing guidelines
* to be literate

Exclusion Criteria:

* Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
* Pregnancy

Primary outcomes:
measure: Canadian Occupational Performance Measurement
timeFrame: change from baseline score at the end of 4 weeks and 6 months
Secondary outcomes:
measure: The DAS 28 Disease Activity scale
timeFrame: change from baseline score at the end of 4 weeks and 6 months
measure: Health Assessment Questionnaire (HAQ)
timeFrame: change from baseline score at the end of 4 weeks and 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: change from baseline score at the end of 4 weeks and 6 months
measure: General Self-Efficacy Scale
timeFrame: change from baseline score at the end of 4 weeks and 6 months
measure: Rheumatoid Arthritis Quality of Life Scale
timeFrame: change from baseline score at the end of 4 weeks and 6 months
measure: The Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)
timeFrame: change from baseline score at the end of 4 weeks and 6 months
Other outcomes:
Locations:
city: Mani̇sa
country: Turkey
facility: Manisa Celal Bayar University Hafsa Sultan Hospital
Study officials:
affiliation: Manisa Celal Bayar University
name: TIMUR PIRILDAR, PROF
role: STUDY_DIRECTOR
References: