NCT06138717

Brief Summary

Axial Spondyloarthritis (AxSpA), mainly affecting the axial skeleton and sacroiliac joints, is a chronic, systemic, inflammatory disease that causes structural and functional disorders. Exercise has a significant role to play in managing treatments. This study aimed to determine the effect of yoga-based exercises combined with aerobic exercise on spinal mobility, disease activity and aerobic capacity in AxSpA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

November 14, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

Axial spondyloarthritis, yoga, aerobic exercise

Outcome Measures

Primary Outcomes (2)

  • VO2 max

    VO2 max is the maximum rate of oxygen consumption attainable during physical exertion

    six week

  • Six minute walk test

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity

    six week

Secondary Outcomes (1)

  • BASMI

    six week

Study Arms (2)

only aerobic exercise

ACTIVE COMPARATOR

Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.

Other: yoga based exercises

combine aerobic exercise and yoga exercises

ACTIVE COMPARATOR

Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session

Other: yoga based exercises

Interventions

Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session

Also known as: aerobic exercises
combine aerobic exercise and yoga exercisesonly aerobic exercise

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Axial spondyloarthritis patients according to ASAS criteria having a stable health condition, having ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, or depression complaints

You may not qualify if:

  • Hemodynamically unstable, cardiac and pulmonary system unstable, with neurological, and psychological disorders patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Axial SpondyloarthritisSpondylitis, Ankylosing

Interventions

Exercise

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

November 18, 2022

Primary Completion

November 15, 2023

Study Completion

January 15, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations