The Effects of Pilates Training on Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis

Investigation of the Effect of Clinical Pilates Training on Functional Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: exercise training group; Other: control training group

Detailed Description

According to sample size calculation 30 patients with RA will be included. Patients will be evaluated before and after treatment. Patients will be randomized into exercise and control training groups. In the exercise training group the patients will be given pilates exercise; in the control training group, the patients will be given relaxation exercise. Pilates exercises will be applied by the physiotherapist 3 days a week for 8 weeks. The patients in the control training group will be given relaxation exercises as a home exercise program 3 days a week for 8 weeks. Exercise capacity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, pain, balance, core stability, dyspnea, functional status, fatigue, quality of life, depression and anxiety will be evaluated.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Selin Bayram, Msc; Phone Number: +905327001805; Email: selinbayram94@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-65 years old
• Being diagnosed according to the American College of Rheumatology (ACR)/EULAR 2010 rheumatoid arthritis diagnostic criteria
• under standard medications

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: exercise training group; Clinical pilates exercises	Other: exercise training group; 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.
Sham Comparator: control training group; Relaxation exercises	Other: control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral muscle strength	Upper and lower extremity muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.	Second day
Pain level	It will be assessed using with Visual Analog Scale (VAS). VAS is a scale which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain). A higher score indicates greater pain intensity.	First day
Balance	The "Biodex Balance System®" will be used to test static balance. As a consequence of the test, the system will provide the general stability index, anterior/posterior (AP) stability index, medial/lateral (ML) stability index, and their standard deviations.	Second day
Core stability	"Core" endurance and "core" power are the specific components of "core" stability and will be evaluated separately. Core muscle endurance times will assessed by using trunk extension, trunk flexion, and side bridge tests. Core power will assessed by using sit-ups ve modified push-ups tests.	Second day
Dyspnea	The Modified Medical Research Council (MMRC) dyspnea scale will be used to determine the perception of dyspnea during activities of daily living. Dyspnea is graded as: zero (shortness of breath with strenuous exercise only); one (shortness of breath when rushing or walking up a slight uphill); two (because of shortness of breath they walk slower than people of the same age or have to stop to breathe while walking at their own pace); three (stops to breathe after walking 100 meters or after a few minutes); and four (too short of breath to leave the house or shortness of breath when getting dressed).	First day
Functional status	Functional status will be assessed by Health Assessment Questionnaire (HAQ). HAQ consists of 20 questions, each question is scored between 0-3. A high score indicates poor functional status.	First day
Fatigue	Fatigue will be evaluated using Turkish version of Fatigue Severity Scale. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue).	Second day
Disease Specific Quality of Life	Quality of life will be evaluated using Turkish version of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire. This questionnaire includes 30 items, each question is scored 0 (no) or 1 (yes). A high score indicates poor quality of life.	Second day
Anxiety and depression	Anxiety and depression will be evaluated using Turkish version of Hospital Anxiety and Depression (HAD) scale. HAD scale uses to determine the risk group of patients in terms of anxiety ad depression and consists of 14 questions. Lowest score that patients can get from both subscales is 0, the highest score 21. The cut-off points for the Turkish version of the HAD scale were 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D).	Second day

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• Yentür SB, Ataş N, Öztürk 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 15, 2024

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; exercise capacity; respiratory muscle strength; respiratory muscle endurance
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 2021-730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No