The Effects of Pilates Training on Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise training group
control training group
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, respiratory muscle strength, respiratory muscle endurance, exercise capacity
Eligibility Criteria
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)
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
exercise training group
control training group
Arm Description
Clinical pilates exercises
Relaxation exercises
Outcomes
Primary Outcome Measures
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
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.
Functional exercise capacity
It will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.
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.
Secondary Outcome Measures
Peripheral muscle strength
Upper and lower extremity muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.
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.
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.
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.
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).
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.
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).
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05240326
Brief Title
The Effects of Pilates Training on Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis
Official Title
Investigation of the Effect of Clinical Pilates Training on Functional Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2022 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, respiratory muscle strength, respiratory muscle endurance, exercise capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise training group
Arm Type
Active Comparator
Arm Description
Clinical pilates exercises
Arm Title
control training group
Arm Type
Sham Comparator
Arm Description
Relaxation exercises
Intervention Type
Other
Intervention Name(s)
exercise training group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control training group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
Time Frame
First day
Title
Respiratory muscle endurance
Description
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.
Time Frame
First day
Title
Functional exercise capacity
Description
It will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.
Time Frame
First day
Title
Pulmonary functions contains dynamic lung volumes
Description
Spirometry will be used to perform pulmonary function testing in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Time Frame
First day
Secondary Outcome Measure Information:
Title
Peripheral muscle strength
Description
Upper and lower extremity muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.
Time Frame
Second day
Title
Pain level
Description
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.
Time Frame
First day
Title
Balance
Description
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.
Time Frame
Second day
Title
Core stability
Description
"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.
Time Frame
Second day
Title
Dyspnea
Description
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).
Time Frame
First day
Title
Functional status
Description
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.
Time Frame
First day
Title
Fatigue
Description
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).
Time Frame
Second day
Title
Disease Specific Quality of Life
Description
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.
Time Frame
Second day
Title
Anxiety and depression
Description
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).
Time Frame
Second day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selin Bayram, Msc
Phone
+905327001805
Email
selinbayram94@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran Oskay, Prof
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33094465
Citation
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.
Results Reference
background
PubMed Identifier
29332746
Citation
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.
Results Reference
background
PubMed Identifier
30782866
Citation
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.
Results Reference
background
PubMed Identifier
31987686
Citation
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.
Results Reference
background
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The Effects of Pilates Training on Exercise Capacity and Respiratory Muscle Performance in Patients With Rheumatoid Arthritis
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