Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
104 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-15
Study Completion Date
2025-12-31
Brief Summary
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Scleroderma (or Systemic Sclerosis - SSc) is one of the most neglected diseases worldwide, according to the World Health Organization. In the adult population with SS, the systemic effects of the disease, such as respiratory and peripheral muscle dysfunction, cause a decrease in quality of life. As a consequence, there is a concern about functional rehabilitation, since the aging of this population is already a reality. Thus, the objective of this project is to evaluate the effects of functional rehabilitation on functional capacity and quality of life in women over 18 years of SS. In this longitudinal intervention study, patients will be submitted to a three-month rehabilitation program. Before and after the intervention, patients will be submitted to the following assessments: Cochin Hand Functional Scale (CHFS), Short-Form 36 Health Survey (SF-36); Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI); lung function; lung ultrasound; handgrip; Glittre Activities of Daily Living test. Thus, it is expected that patients with SS will benefit significantly, with a consequent improvement in musculoskeletal function and , functional capacity and health-related quality of life.
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Detailed Description
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In the current epidemiological context, chronic diseases affect very specific and neglected populations. In addition to their rarity, these diseases are characterized by a progressive increase in the life expectancy of their patients and important functional limitations due to their multisystemic character. In this context, there is Systemic Sclerosis - SSc (or Scleroderma), which presents peculiar clinical and functional aspects that limit the activities of daily living (ADL) of patients. Although the focus of SSc treatment is the clinical control of the disease, a new perspective must be given to the aspect of functional rehabilitation. Therefore, this study proposes a therapist-oriented home rehabilitation program (TOHR) for these patients. Considering that in SSc the hands are predominantly affected, and that functional incapacity of the hands is the main component of global incapacity in this population, the ADL-Glittre test has been used as a submaximal functional capacity test as it involves lower and upper limbs, as well as diversified tasks, coming closer to the activities that the individual does in its usual environment. Thus, the present study aims to evaluate the effects of a TOHR program on the functional capacity of patients with SSc, through the ADL-Glittre test, considering the impact of hand function, peripheral muscle strength, pulmonary function and quality of life. For this, women with SSc will be evaluated, submitted to the following tests: Cochin Hand Functional Scale, Short-Form 36 Health Survey; Scleroderma Health Assessment Questionnaire Disability Index; handgrip dynamometry; impulse oscillometry technique; spirometry; lung ultrasound and ADL-Glittre test. Additionally, patients will undergo a 12-week TOHR protocol. At the end of this period, all evaluations will be repeated. This will be a prospective, longitudinal study, with quantitative assessment of sample data. The aim of the study is to support the applicability of a TOHR program in women with SSc.
Conditions
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Scleroderma
System; Sclerosis
Muscle Strain
Physical Disability
Quality of Life
Exercise
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Women with Scleroderma will use a booklet-guided rehabilitation program that lasts three months (3 times per week with a duration of 60 minutes per session). Consisting of stretching, warm-up and cool-down exercises, muscle strengthening (flexion, extension, adduction, and abduction movements in exercises involving open and closed kinetic chains), endurance exercises, aerobic training, balance training and proprioception. The patient will be evaluated at 2 different timepoints (baseline and after 12 weeks of training). The physiotherapist contacts the patient by phone weekly to follow the progression of the treatment. Before and after the intervention, patients will be submitted to the following assessments: Cochin Hand Functional Scale (CHFS), Short-Form 36 Health Survey (SF-36); Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI); lung function; lung ultrasound; handgrip; Glittre Activities of Daily Living test.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Study group
The program comprises the practice of warm-up, muscle strengthening with free weights and with their own body weight against the action of gravity for the main muscular groups, balance control training, aerobic training, and relaxation exercises. The proposal consists of 3 weekly sessions, for 12 consecutive weeks.
Group Type
EXPERIMENTAL
Treatment
Intervention Type
OTHER
After a physical therapy evaluation, the patient underwent a booklet-guided physical exercise program that lasted three months (3 times per week with a duration of 60 minutes per session). Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit. The patient was evaluated at 2 different timepoints (baseline and after treatment). The physiotherapist contacted the patient by phone weekly to follow the progression of the treatment.
Interventions
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Treatment
After a physical therapy evaluation, the patient underwent a booklet-guided physical exercise program that lasted three months (3 times per week with a duration of 60 minutes per session). Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit. The patient was evaluated at 2 different timepoints (baseline and after treatment). The physiotherapist contacted the patient by phone weekly to follow the progression of the treatment.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Women with Scleroderma, older than 18 years
* Clinical stability
* Signature of the Informed Consent Term (TCLE)
* Clinical stability
* Signature of the Informed Consent Term (TCLE)
Exclusion Criteria
* Patients with inability to perform the Glittre Activities of Daily Living test
* Patients who have cognitive impairment by mini mental state examination (MEEN).
* Abandonment of treatment of scleroderma during the application of the protocol.
* Uncontrolled hypertension (\> 180/100 mmHg with medication use)
* Use of psychotropic drugs
* Any significant limitations due to osteoarthropathy
* History of surgery in the previous six months with exercise restriction
* IPAQ with very active classification
* Patients who have cognitive impairment by mini mental state examination (MEEN).
* Abandonment of treatment of scleroderma during the application of the protocol.
* Uncontrolled hypertension (\> 180/100 mmHg with medication use)
* Use of psychotropic drugs
* Any significant limitations due to osteoarthropathy
* History of surgery in the previous six months with exercise restriction
* IPAQ with very active classification
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Centro Universitário Augusto Motta
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Centro Universitário Augusto Motta
Rio de Janeiro, , Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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Walker UA, Tyndall A, Czirjak L, Denton C, Farge-Bancel D, Kowal-Bielecka O, Muller-Ladner U, Bocelli-Tyndall C, Matucci-Cerinic M. Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR Scleroderma Trials And Research group database. Ann Rheum Dis. 2007 Jun;66(6):754-63. doi: 10.1136/ard.2006.062901. Epub 2007 Jan 18.
Reference Type
BACKGROUND
Wollheim FA. Classification of systemic sclerosis. Visions and reality. Rheumatology (Oxford). 2005 Oct;44(10):1212-6. doi: 10.1093/rheumatology/keh671. Epub 2005 May 3.
Reference Type
BACKGROUND
de Alegria SG, Litrento PF, de Oliveira Farias I, Mafort TT, Lopes AJ. Can home rehabilitation impact impulse oscillometry and lung ultrasound findings in patients with scleroderma-associated interstitial lung disease? A pilot study. BMC Res Notes. 2022 May 15;15(1):176. doi: 10.1186/s13104-022-06064-6.
Reference Type
DERIVED
Related Links
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https://doi.org/10.1590/S1807-59322011000500004
Translation, cultural adaptation and reproducibility of the Cochin Hand Functional Scale questionnaire for Brazil
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwiYpu-H8tPwAhW-qJUCHRUjANgQFjAAegQIAhAD&url=http%3A%2F%2Fwww.saude.ufpr.br%2Fportal%2Flabsim%2Fwp-content%2Fuploads%2Fsites%2F23%2F2016%2F07%2FSuple_139_45_11-Espirometria.pdf&usg=AOvVaw1UGXp51DUZsTOXA2rjdVOy
Pereira CAC. Espirometria. J Bras Pneumol. 2002; 28(Supl. 3): 1-82.
Other Identifiers
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02794918.1.0000.5259
Identifier Type: -
Identifier Source: org_study_id
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