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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05240326
Enrollment
30
Registered
2022-02-15
Start date
2022-03-15
Completion date
2024-03-15
Last updated
2022-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, respiratory muscle strength, respiratory muscle endurance, exercise capacity

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.

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.

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.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strengthFirst dayMaximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
Respiratory muscle enduranceFirst dayIt 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 capacityFirst dayIt will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.
Pulmonary functions contains dynamic lung volumesFirst daySpirometry will be used to perform pulmonary function testing in accordance with the American Thoracic Society and European Respiratory Society guidelines.

Secondary

MeasureTime frameDescription
BalanceSecond dayThe 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 stabilitySecond dayCore 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.
Disease Specific Quality of LifeSecond dayQuality 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.
Functional statusFirst dayFunctional 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.
FatigueSecond dayFatigue 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).
DyspneaFirst dayThe 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).
Anxiety and depressionSecond dayAnxiety 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).
Peripheral muscle strengthSecond dayUpper and lower extremity muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.
Pain levelFirst dayIt 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSelin Bayram, Msc
selinbayram94@gmail.com+905327001805

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026