NCT05987111

Brief Summary

This study was planned to examine and compare the effectiveness of two different pilates exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing Spondylitis(AS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

August 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 4, 2023

Last Update Submit

August 13, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Bath Ankylosing Spondylitis Metrology Index

    This index consists of 5 measurements: cervical rotation, tragus to wall distance, lumbar side flexion, modified Schober's, intermalleolar distance.

    10 minutes

  • Bath Ankylosing Spondylitis Disease Activity Index

    BASDAI consists of 6 questions evaluating the patient's level of weakness/fatigue, spinal pain, joint pain/swelling and sensitivity to touch, and duration of morning stiffness in the last week.

    5minutes

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    This scale, which evaluates the functional limitation of AS patients in activities of daily living, consists of 10 questions.

    5 minutes

  • Ankylosing Spondylitis Quality of Life Questionnaire

    This questionnaire, which evaluates disease-specific quality of life, consists of 18 questions

    5 minutes

  • Maastrich Ankylosing Spondylitis Enthesitis Score

    Its validity and reliability were defined to evaluate enthesopathy and peripheral joint involvement.

    5minutes

  • Multidimensional Assessment of Fatigue Scale

    MAF scale evaluates the level of fatigue during daily activities in the last week.

    5 minutes

  • Biopsychosocial Questionnaire (BETY-BQ)

    The BETY-BQ evaluates the biopsychosocial status of patients with rheumatic diseases.

    10minutes

Study Arms (2)

Mat Pilates

ACTIVE COMPARATOR

Mat Pilates Exercises

Behavioral: Pilates

Reformer Pilates

EXPERIMENTAL

Reformer Pilates Exercises

Behavioral: Pilates

Interventions

PilatesBEHAVIORAL

Pilates exercises were applied twice a week for 4 weeks in both groups. The sessions were supervised by an Australian Physiotherapy and Pilates Institute (APPI) certified physiotherapist as 5 minutes of warm-up, 45 minutes of exercise and 5 minutes of cool-down periods.

Mat PilatesReformer Pilates

Eligibility Criteria

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

You may qualify if:

  • Being in the age range of 20-65, using stable medication for at least 3 months, being sedentary (Not regularly participating in exercise activities for the past 3 months).

You may not qualify if:

  • the presence of cardiovascular, pulmonary, orthopedic and neurological problems, another rheumatic disease, being pregnant, inability to participate in at least 75% of the exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak University

Uşak, Merkez, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

August 2, 2022

Primary Completion

December 15, 2022

Study Completion

February 10, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations