Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Clinical pilates exercise
Aerobic exercise
Clinical Pilates and Aerobic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arhritis, Pilates exercises, Fatigue
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Gazi UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Clinical pilates exercise
Aerobic exercise
Clinical pilates and Aerobic exercise
Arm Description
Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
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.
Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Beck Depression Inventory
The Beck Depression Inventory (BDI) is world-wide among the most used selfrating scales for measuring depression. BDI consists of 21 items related to depressive symptoms such as pessimism, sense of failure, guilt, dissatisfaction, sleep, appetite and fatigue. Each item is scored between 0 and 3. Total score is 63, and an increase of the score means increased severity of depression. According to this scale 1-10 points are defined as normal, scores between 11-16 indicate mild mental distress, 17-20 indicate the patient is at the border points for clinical depression, 21-30 indicate moderate depression, severe depression scores are between 31-40 and 40 points above are interpreted as a very serious depression.
Short Form McGill Pain Questionnaire
This questionnaire consists of 11 sensory and 4 affective descriptive words. These 15 words are described as 0 = absent, 1 = mild, 2 = moderate, 3 = severe pain. So three type of pain scores (sensory, affective, total = sensory + affective) are obtained. In McGill Pain Questionnaire, the current level of pain is measured by Visual Analog Scale (VAS) and Likert scale consisting of 6 points (0 = no pain, 1 = mild, 2 = irritating, 3 = bothersome, 4 = terrible, 5 = unbearable).
Pittsburgh Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
Disease Activity Score- 28
Disease Activity Score (DAS) is an assessment tool used to measure the level of disease activity in patients with RA. The DAS combines information from swollen joints, tender joints, erythrocyte sedimentation rate (ESR), and patient self-report of general health
The Rheumatoid Arthritis Quality of Life Questionnaire
The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific quality of life measure that was developed simultaneously in the UK and the Netherlands. The content of the RAQoL was derived from in-depth qualitative interviews with RA patients exploring.
the impact of RA on their QoL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03836820
Brief Title
Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
Official Title
Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
October 2019 (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 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.
Detailed Description
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterised by polyarthritis and erosive synovitis and is associated with progressive impairments and activity limitations. It may cause destruction of bone and cartilage by affecting synovial joints symmetrically. Organ involvement may be seen in the patients with RA as well as joint involvement. Initiation of the disease is mostly insidious and varies from patient to patient. Hand, wrist, foot, elbow and knee joints involvement are common. Furthermore almost all joints may be affected. Extraarticular symptoms are subcutaneous nodules, visceral nodules, cardiologic involvement, pulmonary involvement, eye involvement, neurological involvement, vasculitis, felty syndrome, amyloidosis, osteoporosis, liver and renal involvements. These symptoms may cause some extra complaints such as depression, fatigue, kinesiophobia and physical inactivity. Studies in literature have reported reduction in physical activity level in patients with RA. Reasons of physical inactivity can be listed as general obstacles such as lack of time, lack of motivation, weather condition and disease related blocks such as pain, fatigue, disease activity, depression, kinesiophobia. Depression prevalence in RA patients is found between 14.8% and 38.8% and this rate is estimated five times more than healthy people. Also, a study investigating pain in RA patients resulted that pain may be correlated with fatigue and depression. Fatigue which is frequently observed complaint of patients with rheumatic diseases is reported incidence between 40% and 80%. RA patients have been reported at high risk for cardiovascular diseases in EULAR recommendations.
Positive effects of physical activity and exercise on physiological, morphological and psychosocial conditions are known. Endurance, flexibility, muscle strength, body composition, self confidence and mood improve by regular exercise and high physical activity level. Furthermore, anti-inflammatory affects of exercise are proved in last years. Aims of pilates exercises which are developed by Joseph Pilates are to increase motor control, range of motion, flexibility, muscle strength and endurance, to improve balance, respiratory pattern and body awareness, to reduce stress. There are many studies investigating affects of pilates exercises on quality of life, functional capacity, posture, pain for different diseases including Multiple Sclerosis, Ankylosing Spondylitis, breast cancer. Aerobic and strengthening exercises reported to have positive affects on fatigue, quality of life, depression and pain for RA patients. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arhritis, Pilates exercises, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical pilates exercise
Arm Type
Experimental
Arm Description
Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinical pilates and Aerobic exercise
Arm Type
Experimental
Arm Description
Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Clinical pilates exercise
Intervention Description
Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Pilates and Aerobic Exercise
Intervention Description
Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.
Primary Outcome Measure Information:
Title
Aerobic capacity
Description
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.
Time Frame
6 minutes
Title
Fatigue severity scale
Description
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
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
The Beck Depression Inventory (BDI) is world-wide among the most used selfrating scales for measuring depression. BDI consists of 21 items related to depressive symptoms such as pessimism, sense of failure, guilt, dissatisfaction, sleep, appetite and fatigue. Each item is scored between 0 and 3. Total score is 63, and an increase of the score means increased severity of depression. According to this scale 1-10 points are defined as normal, scores between 11-16 indicate mild mental distress, 17-20 indicate the patient is at the border points for clinical depression, 21-30 indicate moderate depression, severe depression scores are between 31-40 and 40 points above are interpreted as a very serious depression.
Time Frame
2 minutes
Title
Short Form McGill Pain Questionnaire
Description
This questionnaire consists of 11 sensory and 4 affective descriptive words. These 15 words are described as 0 = absent, 1 = mild, 2 = moderate, 3 = severe pain. So three type of pain scores (sensory, affective, total = sensory + affective) are obtained. In McGill Pain Questionnaire, the current level of pain is measured by Visual Analog Scale (VAS) and Likert scale consisting of 6 points (0 = no pain, 1 = mild, 2 = irritating, 3 = bothersome, 4 = terrible, 5 = unbearable).
Time Frame
1 minute
Title
Pittsburgh Sleep Quality
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
Time Frame
2 minutes
Title
Disease Activity Score- 28
Description
Disease Activity Score (DAS) is an assessment tool used to measure the level of disease activity in patients with RA. The DAS combines information from swollen joints, tender joints, erythrocyte sedimentation rate (ESR), and patient self-report of general health
Time Frame
10 minutes
Title
The Rheumatoid Arthritis Quality of Life Questionnaire
Description
The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific quality of life measure that was developed simultaneously in the UK and the Netherlands. The content of the RAQoL was derived from in-depth qualitative interviews with RA patients exploring.
the impact of RA on their QoL.
Time Frame
2 minutes
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:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul Baglan Yentur
Phone
+90 312 216 26 12
Email
songulbaglan23@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deran Oskay
Organizational Affiliation
Gazi University Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul Baglan Yentur
First Name & Middle Initial & Last Name & Degree
Nuh Atas
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Ozturk
First Name & Middle Initial & Last Name & Degree
Deran Oskay
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23078261
Citation
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.
Results Reference
result
PubMed Identifier
25624016
Citation
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.
Results Reference
result
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
derived
Learn more about this trial
Effects of Clinical Pilates Exercises in Patients With Rheumatoid Arthritis
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