NCT03836820

Brief Summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis. Articular and extraarticular sympthoms are mostly seen in patients with RA. Additionally, extra complaints such as depression, fatigue, kinesiophobia and physical inactivity may accompany. Positive effects of physical activity and exercise are known. In some studies, effects of pilates exercises have been investigated on many different diseases such as Multiple Sclerosis, Ankylosing Spondylitis and breast cancer. The aim of this study is to investigate effects of clinical pilates exercises on fatigue, depression, aerobic capacity, pain, quality of life, disease activity and sleep quality.

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 Dec 2018

Shorter than P25 for not_applicable rheumatoid-arthritis

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

Study Start

First participant enrolled

December 24, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

February 6, 2019

Last Update Submit

February 8, 2019

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArhritisPilates exercisesFatigue

Outcome Measures

Primary Outcomes (2)

  • Aerobic capacity

    The 6-minute walk test is a submaximal exercise test used to quantify the functional exercise capacity in clinical populations. It measures the distance walked within a period of 6-minutes.

    6 minutes

  • Fatigue severity scale

    Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7

    2 minutes

Secondary Outcomes (5)

  • Beck Depression Inventory

    2 minutes

  • Short Form McGill Pain Questionnaire

    1 minute

  • Pittsburgh Sleep Quality

    2 minutes

  • Disease Activity Score- 28

    10 minutes

  • The Rheumatoid Arthritis Quality of Life Questionnaire

    2 minutes

Study Arms (3)

Clinical pilates exercise

EXPERIMENTAL

Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Other: Clinical pilates exerciseOther: Clinical Pilates and Aerobic Exercise

Aerobic exercise

EXPERIMENTAL

Progressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks.

Other: Aerobic exerciseOther: Clinical Pilates and Aerobic Exercise

Clinical pilates and Aerobic exercise

EXPERIMENTAL

Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.

Other: Clinical pilates exerciseOther: Aerobic exerciseOther: Clinical Pilates and Aerobic Exercise

Interventions

Clinical pilates exerciseOTHER

Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.

Clinical pilates and Aerobic exerciseClinical pilates exercise
Aerobic exerciseOTHER

Progressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks.

Aerobic exerciseClinical pilates and Aerobic exercise
Clinical Pilates and Aerobic ExerciseOTHER

Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.

Aerobic exerciseClinical pilates and Aerobic exerciseClinical pilates exercise

Eligibility Criteria

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

You may qualify if:

  • Patients between the ages of 18 to 65 and who have diagnosed with RA according to American College of Rheumatology criteria will be included the study.

You may not qualify if:

  • Patients who were pregnant, diagnosed with malignancy, had changes of medical treatment in the last 3 months, had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits, had regular exercise habit (minimally three days in a week), had high disease activity score (DAS-28\>3.2) and had cardiac symphtoms according to New YorkHeart Association will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Munsterman T, Takken T, Wittink H. Are persons with rheumatoid arthritis deconditioned? A review of physical activity and aerobic capacity. BMC Musculoskelet Disord. 2012 Oct 18;13:202. doi: 10.1186/1471-2474-13-202.

    PMID: 23078261RESULT

  • Rongen-van Dartel SA, Repping-Wuts H, Flendrie M, Bleijenberg G, Metsios GS, van den Hout WB, van den Ende CH, Neuberger G, Reid A, van Riel PL, Fransen J. Effect of Aerobic Exercise Training on Fatigue in Rheumatoid Arthritis: A Meta-Analysis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1054-62. doi: 10.1002/acr.22561.

    PMID: 25624016RESULT

  • 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: 33094465DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Deran Oskay

    Gazi University Faculty of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

Songul Baglan Yentur

CONTACT

+90 312 216 26 12songulbaglan23@hotmail.com

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
Research Assistant

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 11, 2019

Study Start

December 24, 2018

Primary Completion

July 1, 2019

Study Completion

October 1, 2019

Last Updated

February 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)