NCT03500276

Brief Summary

The purpose of this study is to investigate the effects of a yoga program based on "Yoga in daily life system" in patients with rheumatoid arthritis. The investigators want to explore whether this program will improve health-related quality of life and psychological well-being in patients. In addition they want to explore its potential positive modulation of the immune system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

April 7, 2018

Last Update Submit

May 11, 2020

Conditions

Rheumatoid Arthritis

Keywords

yogahealth-related quality of lifeproinflammatory genesinflammatory markersrheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in health-related quality of life

    The Medical Outcomes Survey 36-item Short-Form Healthy Survey ( SF-36). A 36 item generic health survey measures general health concepts through 8 domains: physical functioning, role physical, bodily pain, global health, vitality, social functioning, role emotional, mental health. Scores 0-100, with higher scores indicating better health

    baseline and 12 weeks

Secondary Outcomes (15)

  • Change in pro-inflammatory gene expression

    baseline and 12 weeks

  • Change in blood levels of hs-CRP

    baseline and 12 weeks

  • Change in blood levels of hs-CRP

    baseline and 24 weeks

  • Change in pain intensity

    baseline and 12 weeks

  • Change in pain intensity

    baseline and 24 weeks

  • +10 more secondary outcomes

Study Arms (2)

Yoga program

EXPERIMENTAL

12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.

Behavioral: Yoga program

Arthritis-education control

ACTIVE COMPARATOR

12 weeks of arthritis - education classes, consisting of 1x weekly sessions for 120 minutes including lectures on arthritis and related issues followed by group discussion.

Behavioral: Arthritis-education

Interventions

Yoga programBEHAVIORAL

Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.

Yoga program
Arthritis-educationBEHAVIORAL

Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.

Arthritis-education control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACR/EULAR 2010. classification criteria for rheumatoid arthritis (RA)
  • disease activity measured by DAS28CRP\< 5.1
  • patients on stable dose of disease-modifying antirheumatic medications,non-steroidal anti-inflammatory drugs or low-dose glucocorticoids for the last 3 months

You may not qualify if:

  • significant co-morbidity (active malignant disease, symptomatic ischemic heart disease or heart failure, severe lung disease, uncontrolled thyroid disease, neurological disease that impairs mobility) that is more limiting than RA
  • history of drug or alcohol abuse
  • recent injury/ or surgery
  • regular practice of yoga or similar technique in the last 6 months or currently engaged in a structured exercise program for \>=2 times weekly, patients that are currently engaged in physical therapy
  • pregnant or planning pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dubrava

Zagreb, 10 000, Croatia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Silva Pukšić, MD

    University Hospital Dubrava

    PRINCIPAL INVESTIGATOR

  • Jadranka Morović-Vergles, MD, PhD

    University Hospital Dubrava

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded rater will be used to assess disease activity by DAS28CRP score.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD candidate

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 18, 2018

Study Start

April 4, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)