Systemic Sclerosis Clinical Trial
Official title:
Comparison of the Effects of a Supervised Exercise Program and a Home Exercise Program in Patients With Systemic Sclerosis
NCT number | NCT04675502 |
Other study ID # | 3701-GOA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2018 |
Est. completion date | April 13, 2021 |
Verified date | February 2021 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Scleroderma, also called systemic sclerosis (SSc); It is a heterogeneous multiorgan disease of unknown etiology characterized by vasculopathy, autoimmunity and fibrous tissue. It is stated in studies that cardiac and pulmonary systems are affected in patients with SSc and these effects affect the aerobic capacity, physical functions and quality of life of patients negatively by disrupting their pulmonary and musculoskeletal functions. However, considering the treatment approaches in scleroderma patients, the number of studies evaluating the effectiveness of pulmonary rehabilitation and exercises is limited. Therefore, the purpose of our study; Comparison of the effects of a supervised exercise program and a home exercise program in patients with Systemic Sclerosis.
Status | Completed |
Enrollment | 37 |
Est. completion date | April 13, 2021 |
Est. primary completion date | April 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility | Inclusion Criteria: - Stable clinical status for at least two weeks - Walking independently - Volunteer for research study Exclusion Criteria: - Having unstable angina - Having uncontrolled hypertension - Having hemodynamic instability - Participating in any exercise program in the last six months - Having a major orthopedic or neurological problem that limits functionality |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylül Üniversitesi School of Physical Therapy and Rehabilitation | Izmir | Izmir, Turkey |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Forced Vital Capacity | Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced vital capacity (FVC) percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria | Baseline, 12th week | |
Primary | Change in Forced Expiratory Volume in One Second | Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced expiratory volume in one second (FEV1) percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria | Baseline, 12th week | |
Primary | Change in Forced expiratory volume in one second / Forced vital capacity | Pulmonary function test was applied by Sensor Medics Vmax 22 0,6-2B version spirometer (ERS 1993 Uptake + Zapleta, SensorMedics, Inc, Anaheim, CA, USA). Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio percent was recorded according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria | Baseline, 12th week | |
Primary | Change in diffusion capacity | Single breath carbon monoxide method was used in diffusion capacity for carbon monoxide (DLCO) percent measurement | Baseline, 12th week | |
Primary | Change in Maximal Expiratory Pressure | Electronic mouth pressure measuring device was used for respiratory muscle strength. Maximal expiratory pressure (MEP) was measured. MEP was measured from total lung capacity performing a maximal expiratory effort against an occluded airway. MEP measurements was repeated three times, and the maximum percent achieved was recorded | Baseline, 12th week | |
Primary | Change in Maximal Inspiratory Pressure | Electronic mouth pressure measuring device was used for respiratory muscle strength. Maximal inspiratory pressure (MIP) was measured. MIP was measured from residual volume upon a maximal inspiratory effort against an occluded airway. occluded airway. MIP measurements was repeated three times, and the maximum percent achieved was recorded. | Baseline, 12th week | |
Primary | Change in functional capacity | Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance. | Baseline, 12th week | |
Primary | Change in peripheral muscle strength | The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. Quadriceps isometric muscle strength is measured with a Hand Held Dynamometer. | Baseline, 12th week | |
Secondary | Change in severity of dyspnoea | Modified Medical Research Council (mMRC) dyspnea scale is a valid and reliable test for measuring the severity of dyspnea. This scale ranges from 0 to 4. A higher value represents a worse outcome | Baseline, 12th week | |
Secondary | Change in fatigue | The Fatigue Impact Scale that questions how much fatigue the scale has experienced in a month, taking as a reference a total of 40 items, including the day of application. Scores between 0 and 4 points are given for each item, and the maximum score is calculated to be 160.High score indicates a high level of fatigue. | Baseline, 12th week | |
Secondary | Change in quality of life:Health Assessment Questionnaire Disability Index | Health Assessment Questionnaire Disability Index (HAQ-DI) measures disability, function and quality of life with 8 functional domains of physical capacity (dress / get up / eat / walk / hygiene / to reach objects / grip / activities) which consists of 20 items. Each item scored between 0 (without any difficulty) and 3 (unable to do). The scale is scored between 0 and 60 and the high score indicates poor health quality status | Baseline, 12th week | |
Secondary | Change in quality of life: Scleroderma Health Assessment Questionnaire | The Scleroderma Health Assessment Questionnaire (SHAQ)-global score which was calculated by adding five SSc-related VAS to eight HAQ-DI domains and dividing the sum by 13. he subscales are scored between 0 and 3 and the high score indicates poor health status | Baseline, 12th week | |
Secondary | Change in quality of life: Short Form-36 Quality of Life Questionnaire | SF-36 measures health-related quality of life and consists of 36 items in total and includes two subscales that are physical and mental. The subscales are scored between 0 and 100 and the low score indicates poor health status | Baseline, 12th week |
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