NCT06000072

Brief Summary

Exercise is a core treatment method in the management of Axial Spondyloarthritis. Clinical guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to reduce disease activity and symptoms and improve physical function. The COVID-19 pandemic has accelerated the provision of healthcare services remotely and the digitalization of rehabilitation services. Telerehabilitation methods provide advantages in terms of transportation, prevention of infections that may occur due to suppression of immunity with drugs, and continuity of treatment in patients with axial spondyloarthritis. In this context, it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery in chronic inflammatory rheumatic diseases. This study, which will examine the effects of telerehabilitation in the disease management processes of individuals with axial spondyloarthritis, is thought to shed light on future studies. The aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded video-based core exercise program on core endurance, disease activity and physical function in subjects with axial spondyloarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 11, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

August 11, 2023

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Core Endurance Tests : Trunk Flexion Test

    The patient will be asked to cross his/her hands over his/her chest and positioned with the trunk in 60° flexion and knees in 90° flexion. The time in this position will be measured and recorded with a stopwatch. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.

    8 weeks

  • Core Endurance Tests : Side Plank (Side Bridge Test):

    The patient will be asked to lie on his/her side on the dominant side and cross his/her foot over the other foot. The non-dominant arm will be crossed over the chest and placed over the dominant shoulder. The patient will be asked to stand on the dominant forearm and elbow. The time in this position will be measured with a cronometer and recorded. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.

    8 weeks

  • Core Endurance Tests : Modified Plank

    The patient will be asked to position on his/her knees and elbows with his/her face to the floor. He/she will be fixed over his/her knees with the help of a belt and the duration of his/her stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.

    8 weeks

  • Core Endurance Tests : Biering-Sorenson Test

    Patients will be positioned in a prone position with their spina iliaca anterior superior to the edge of the bed. Participants will be asked to extend their upper body straight forward from the edge of the table. They will be immobilized over their knees with the help of a belt and the time they stay in this position will be measured and recorded with a cornometer. If there is any deterioration in the patient's position, the stopwatch will be stopped and the test will be terminated.

    8 weeks

Secondary Outcomes (8)

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    8 weeks

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    8 weeks

  • Bath Ankylosing Spondylitis Metrology Index (BASMI)

    8 weeks

  • Global Rating of Change (GROC)

    8 weeks

  • Pain intensity (Numeric Rating Scale/NRS)

    8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Telerehabilitation sessions including core exercises

Other: Core Exercise Program

Video-based

ACTIVE COMPARATOR

Core exercises by watching pre-recorded videos

Other: Core Exercise Program

Interventions

Core exercises

TelerehabilitationVideo-based

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old,
  • Axial Spondyloarthritis diagnosed by a rheumatologist,
  • Not having any orthopedic, neurological, or mental illness that would affect exercise,
  • Not using any assistive device for ambulation
  • People who volunteer to participate

You may not qualify if:

  • Pregnancy, malignancy, and recent surgery
  • Presence of cardiopulmonary disease
  • Patients with endoprosthesis and prosthesis
  • Attending a regular exercise program (Pilates, core, or yoga etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haydarpasa Numune Research and Training Hospital

Istanbul, 34752, Turkey (Türkiye)

Location

Acıbadem Mehmet Ali Aydınlar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Sen EN, Saritas F, Ozturk O. Synchronous and asynchronous remote core stability exercises in patients with axial spondyloarthritis: a randomized-controlled clinical trial. Ir J Med Sci. 2025 Feb;194(1):137-146. doi: 10.1007/s11845-024-03846-8. Epub 2024 Nov 26.

MeSH Terms

Conditions

Axial SpondyloarthritisMotor Activity

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 21, 2023

Study Start

August 11, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations