NCT05240326

Brief Summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with significant functional impairment and increased risk for cardiovascular and pulmonary disease. Along with pharmacological therapy, exercise seems to be a very promising intervention to improve disease-related outcomes, including functional capacity and systemic manifestations. Despite the fact that aerobic and strengthening exercises have been shown to be useful in patients with RA, there have been limited research on the effects of pilates training. Therefore, we aimed to investigate the effect of clinical pilates training on exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety in patients with RA.

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
30

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 5, 2022

Last Update Submit

February 15, 2022

Conditions

Keywords

rheumatoid arthritisrespiratory muscle strengthrespiratory muscle enduranceexercise capacity

Outcome Measures

Primary Outcomes (4)

  • Respiratory muscle strength

    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.

    First day

  • Respiratory muscle endurance

    It will be assessed using an incremental threshold loading test, in which patients began with a load of 30% of maximum inspiratory pressure and increased by 10% every 2 minutes.

    First day

  • Functional exercise capacity

    It will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.

    First day

  • Pulmonary functions contains dynamic lung volumes

    Spirometry will be used to perform pulmonary function testing in accordance with the American Thoracic Society and European Respiratory Society guidelines.

    First day

Secondary Outcomes (9)

  • Peripheral muscle strength

    Second day

  • Pain level

    First day

  • Balance

    Second day

  • Core stability

    Second day

  • Dyspnea

    First day

  • +4 more secondary outcomes

Study Arms (2)

exercise training group

ACTIVE COMPARATOR

Clinical pilates exercises

Other: exercise training group

control training group

SHAM COMPARATOR

Relaxation exercises

Other: control training group

Interventions

All exercise program will be applied during supervised session by a physiotherapist. Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks. The program consisted of 10 minutes warm-up exercises, clinical pilates-based exercises on mat for 40 minutes and 10 minutes relaxation and stretching exercises.

exercise training group

The control group will be followed up as a home program by giving the relaxation exercises. Patients will be asked to do the exercises regularly for 3 days/week, 1 sessions/day, for eight weeks. Patients in the control group will be followed up by phone once a week.

control training group

Eligibility Criteria

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

You may qualify if:

  • years old
  • Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria
  • under standard medications

You may not qualify if:

  • orthopedic or neurological disease with a potential to affect functional capacity
  • have problems that can prevent evaluation
  • have a neurological problem that may cause hearing or vision impairment
  • changes in medical treatment in the last 3 months
  • have high disease activity score (DAS-28\>3.2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Yentur SB, Atas N, Ozturk MA, Oskay D. Comparison of the effectiveness of pilates exercises, aerobic exercises, and pilates with aerobic exercises in patients with rheumatoid arthritis. Ir J Med Sci. 2021 Aug;190(3):1027-1034. doi: 10.1007/s11845-020-02412-2. Epub 2020 Oct 22.

    PMID: 33094465BACKGROUND
  • Byrnes K, Wu PJ, Whillier S. Is Pilates an effective rehabilitation tool? A systematic review. J Bodyw Mov Ther. 2018 Jan;22(1):192-202. doi: 10.1016/j.jbmt.2017.04.008. Epub 2017 Apr 26.

    PMID: 29332746BACKGROUND
  • Silva HJA, Lins CAA, Nobre TTX, de Sousa VPS, Caldas RTJ, de Souza MC. Mat Pilates and aquatic aerobic exercises for women with fibromyalgia: a protocol for a randomised controlled blind study. BMJ Open. 2019 Feb 19;9(2):e022306. doi: 10.1136/bmjopen-2018-022306.

    PMID: 30782866BACKGROUND
  • Kucukdeveci AA. Nonpharmacological treatment in established rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2019 Oct;33(5):101482. doi: 10.1016/j.berh.2019.101482. Epub 2020 Jan 25.

    PMID: 31987686BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Deran Oskay, Prof

    Gazi University

    STUDY DIRECTOR

Central Study Contacts

Selin Bayram, Msc

CONTACT

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
Principal Investigator

Study Record Dates

First Submitted

February 5, 2022

First Posted

February 15, 2022

Study Start

March 15, 2022

Primary Completion

March 1, 2024

Study Completion

March 15, 2024

Last Updated

March 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations