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Examining the Efficacy of Personalized Lifestyle Intervention in Individuals With Rheumatoid Arthritis

H

Hacettepe University

Status

Enrolling

Conditions

Inflammatory Arthritis

Treatments

Behavioral: person-centered lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05759585
HU-SBASTURK-001

Details and patient eligibility

About

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.

Full 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:

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Person-centered lifestyle intervention group
Experimental group
Description:
Intervention group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study. Person-centered lifestyle intervention in individuals with rheumatoid arthritis is planned as 2 sessions per week, for a total of 4 weeks.
Treatment:
Behavioral: person-centered lifestyle intervention
Control group
Experimental group
Description:
Control group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study. For the control group, they will be called twice a week for 4 weeks and inquired about their general condition.
Treatment:
Behavioral: person-centered lifestyle intervention

Trial contacts and locations

1

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Central trial contact

GAMZE EKICI CAGLAR, PROF; SULTAN BASTURK

Data sourced from clinicaltrials.gov

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