NCT04281238

Brief Summary

The aim of the study is to investigate the effect of yoga training on functional level, disease activity, spinal mobility, balance, sleep quality, depression and quality of life in AS patients.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

February 20, 2020

Last Update Submit

January 8, 2021

Conditions

Ankylosing SpondylitisYoga

Keywords

ankylosing spondylitisyoga

Outcome Measures

Primary Outcomes (1)

  • Bath Ankylosing Spondylitis Spinal Metrology Index (BASMI)

    Asses spinal mobility. The total score ranges from 0 to 10. Higher scores mean poor spinal mobility.

    5 minutes

Secondary Outcomes (7)

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    2 minutes

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    3 minutes

  • Short Form-36 (SF-36)

    6 minutes

  • Beck Depression Inventory

    5 minutes

  • Beck Anxiety Inventory

    4 minutes

  • +2 more secondary outcomes

Study Arms (2)

yoga group

EXPERIMENTAL

Participants in this group will be given yoga training 3 days a week for 8 weeks. In addition, patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.

Other: Yoga group

Control group

OTHER

Patients in this group will be taught home exercises and asked to do these exercises 5 days a week for 8 weeks.

Other: Control group

Interventions

Yoga groupOTHER

Yoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks

yoga group
Control groupOTHER

Home exercises 5 days a week for 8 weeks

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria
  • To be volunteer

You may not qualify if:

  • the presence of peripheral enthesitis, orthopedic disorders, cardiovascular disorders, neurological disorders, visual and auditory deficits,
  • history of surgery for spine or lower limb,
  • failure to complete the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Eyalet/Yerleşke, 35320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

October 26, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

TU(1)