Rehabilitation Program in Patients With Scleroderma

NCT05041868 | Unknown DMC

• 1 other identifier: 02794918.1.0000.5259
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scleroderma; System; Sclerosis; Muscle Strain; Physical Disability; Quality of Life; Exercise

Keywords

Scleroderma; Physical Therapy; Rehabilitation; Functional capacity; Exercise; ADL-Glittre test

Outcome Measures

Primary Outcomes (1)

• Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test) before and after the execution of the treatment plan

  Performed as proposed by Skumlien et al. (2006), the participant must complete 5 laps in the shortest possible time. The test consists of carrying a backpack containing a 2.5 kg weight completing a circuit with the following activities. The participant rises from a seated position and walks on a 10-m flat course, interposed halfway by a stairway with 2 steps to ascend and 2 to descend. After completing the course, the individual approaches a 2-teir shelf containing 3 objects weighing 1 kg each, placed on the highest shelf (shoulder height), that must be moved 1 by 1 to the bottom shelf (waist height) and then down to the floor. Then, the objects are placed on the bottom shelf again and finally on the top shelf. Then, the individual turns and walks back over the course; immediately after completion of 1 lap, another lap is started, completing the same circuit. The instructions are standardized, and there is no incentive during the test. Two tests are performed with a minim.

  twelve weeks

Secondary Outcomes (6)

• Peripheral muscle function before and after the execution of the treatment plan

  twelve weeks

• Cochin Hand Functional Scale (CHFS)

  twelve weeks

• Quality of life related to activities of daily living through the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) before and after the execution of the treatment plan.

  twelve weeks

• Pulmonary Function Tests before and after the execution of the treatment plan

  twelve weeks

• Lung ultrassound before and after the execution of the treatment plan

  twelve weeks

Study Arms (1)

Study group

EXPERIMENTAL

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.

Other: Treatment

Interventions

Treatment 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.

Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Scleroderma is more frequent in females than in males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with Scleroderma, older than 18 years
• Clinical stability
• Signature of the Informed Consent Term (TCLE)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitário Augusto Motta: lead

Study Sites (1)

Centro Universitário Augusto Motta

Rio de Janeiro, 22745271, Brazil

RECRUITING

Related Publications (50)

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Related Links

• Translation, cultural adaptation and reproducibility of the Cochin Hand Functional Scale questionnaire for Brazil
• Pereira CAC. Espirometria. J Bras Pneumol. 2002; 28(Supl. 3): 1-82.

MeSH Terms

Conditions

Scleroderma, Diffuse; Sprains and Strains; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Wounds and Injuries; Behavior

Central Study Contacts

Samantha Alegria, MsC

CONTACT

+55 (21) 992936572; s.gomesdealegria13@gmail.com

Agnaldo Lopes, PhD

CONTACT

+55 (21) 25762030; agnaldolopes.uerj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: October 15, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)