Official title: Physical Rehabilitation in Women With Scleroderma: Effects on Pulmonary Function, Lung Ultrasound, Muscle Function, Hand Functional, Functional Capacity, and Quality of Life

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.

Read the detailed description

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: Scleroderma, System; Sclerosis, Muscle Strain, Physical Disability, Quality of Life, Exercise
Being tested: Treatment
Keywords: Scleroderma, Physical Therapy, Rehabilitation, Functional capacity, Exercise, ADL-Glittre test
Medical subject headings: Scleroderma, Diffuse, Sprains and Strains, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TreatmentOther
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 groups in NCT05041868
Study group	Role	What they receive
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. Receives: Other: Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: twelve weeks

Secondary outcomes (6)

Peripheral muscle function before and after the execution of the treatment plan
Isometric handgrip strength (IHGS) was measured using a hydraulic isometric dynamometer (SH5001, Saehan Corporation, Korea) with the hand on the dominant side of the body. Participants were comfortably seated in a chair with no arm rest, with the feet flat on the floor and hips and knees flexed at 90°. The shoulder was adducted, the elbow was flexed at 90º, and the forearm was in a neutral position; the wrist position could vary between 0-30º of extension and 0-15º of ulnar deviation. The participants were then instructed to perform 3 maximum voluntary contractions with a 60-s interval in between. The tests followed the standards established by the American Society of Hand Therapists. The highest recorded value among the 3 measurements was considered.
Measured: twelve weeks
Cochin Hand Functional Scale (CHFS)
The CHFS was used to assess the level of hand ability and functionality in the performance of daily activities. The CHFS contains 18 items concerning ADLs that require manual skills, such as cooking, dressing and personal hygiene. This scale takes approximately 3 min to complete and considers only the experiences of the individual during the past month. Each item has 6 possible answers, as follows: without difficulty (0); with very little difficulty (1); with some difficulty (2); with much difficulty (3); nearly impossible to do (4); and impossible to do (5). The score is the sum of all items and ranges from 0 to 90; the higher the score is, the greater the hand dysfunction.
Measured: 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.
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. Patients or individuals are asked to fill out the questionnaire (tick boxes) by themselves and then it is scored by a researcher. It contains the 36 questions and answers in the bodily pain and general health domains.Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL. Two component scores can also be tallied; a physical component summary and a mental component summary.
Measured: twelve weeks
Pulmonary Function Tests before and after the execution of the treatment plan
Impulse oscillometry (IOS) will use an impulse oscillometer (Quark i2m, Cosmed, Rome, Italy). IOS measures the respiratory system impedance (Zrs) composed of the respiratory system resistance and the respiratory system reactance. The minimum acceptable coherence values will be those ≥ 0.9 Hz. (RIBEIRO et al, 2018) Participants will also perform spirometry (VT 130 SL, Codax Ltda, Rio de Janeiro, Brazil), using standardization made by the American Thoracic Society/European Respiratory Society. The predicted values of FVC, expiratory volume in one second (FEV1) and forced expiratory flow between 25-75% of FVC (FEF25-75%) will be calculated according to the equations of Pereira et al (2007) and the results will be expressed as percentages of the predicted values. Obstructive disorder will be defined by an FEV1/FVC ratio <70%, while a restrictive disorder will be inferred by a FVC <80% predicted in the absence of reduced expiratory flows.
Measured: twelve weeks
Lung ultrassound before and after the execution of the treatment plan
Using an Aplio XG Aplio XG equipment (Toshiba Medical Systems, Tokyo, Japan), with a 7.5-10 MHz multifrequency linear transducer or a 3.5-5 MHz convex transducer in B mode, the USP exams will be performed on the same day as the TFP. Following a 12-zone protocol and with participants in a seated position, the USP exams will be performed in 6 areas of each hemithorax (two anterior, two lateral and two posterior). USP images will be examined for the evaluation of the following signs: B lines > 2, coalescent B lines and subpleural consolidations. In order to classify the lung injury, in each of these 6 areas, weights ranging from 1 to 3 will be assigned for each finding in the USP, as follows: 1 = lines B > 2; 2 = coalescent B lines; and 3 = subpleural consolidations). The sum of all 6 areas evaluated at USP will represent the aeration score, which may vary between 0-18 points. (SOUMMER et al., 2012; TUNG-CHEN et al., 2020)
Measured: twelve weeks
Disability assessment using the Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) before and after the execution of the treatment plan
The SHAQ-DI will be used to assess the participants' level of physical function. This questionnaire includes questions related to fine movements of the upper extremities and motor activities of the lower limbs (BRUCE \& FRIES, 2003). There are 20 questions divided into 8 categories that represent a comprehensive set of functional activities performed in the last 7 days, including the ability to dress, stand up, eat, walk, perform personal hygiene, reach or grab something, and perform usual activities . To quantify the values found, the SHAQ-DI has a 26 score ranging from 0 (no disability) to 3 (maximum disability). The total score is the average of the scores of the 8 categories.
Measured: twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202131 Dec 2025

First posted13 Sep 2021
Study start15 Oct 2021
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (50)Papers the sponsor has linked to this study.
Other trials for SclerodermaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 104 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05041868
Sponsor's protocol ID: 02794918.1.0000.5259
Status last verified: Jul 2023
First submitted: 3 Sep 2021
Last updated: 8 Aug 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alhajeri H, Hudson M, Fritzler M, Pope J, Tatibouet S, Markland J, Robinson D, Jones N, Khalidi N, Docherty P, Kaminska E, Masetto A, Sutton E, Mathieu JP, Ligier S, Grodzicky T, LeClercq S, Thorne C, Gyger G, Smith D, Fortin PR, Larche M, Baron M. 2013 American College of Rheumatology/European League against rheumatism classification criteria for systemic sclerosis outperform the 1980 criteria: data from the Canadian Scleroderma Research Group. Arthritis Care Res (Hoboken). 2015 Apr;67(4):582-7. doi: 10.1002/acr.22451.
PubMed 25233870
Avouac J, Walker U, Tyndall A, Kahan A, Matucci-Cerinic M, Allanore Y; EUSTAR; Miniati I, Muller A, Iannone F, Distler O, Becvar R, Sierakowsky S, Kowal-Bielecka O, Coelho P, Cabane J, Cutolo M, Shoenfeld Y, Valentini G, Rovensky J, Riemekasten G, Vlachoyiannopoulos P, Caporali R, Jiri S, Inanc M, Zimmermann Gorska I, Carreira P, Novak S, Czirjak L, Oliveira Ramos F, Jendro M, Chizzolini C, Kucharz EJ, Richter J, Cozzi F, Rozman B, Mallia CM, Gabrielli A, Farge D, Kiener HP, Schoffel D, Airo P, Wollheim F, Martinovic D, Trotta F, Jablonska S, Reich K, Bombardieri S, Siakka P, Pellerito R, Bambara LM, Morovic-Vergles J, Denton C, Hinrichs R, Van den Hoogen F, Damjanov N, Kotter I, Ortiz V, Heitmann S, Krasowska D, Seidel M, Hasler P, Van Laar JM, Kaltwasser JP, Foeldvari I, Juan Mas A, Bajocchi G, Wislowska M, Pereira Da Silva JA, Jacobsen S, Worm M, Graniger W, Kuhn A, Stankovic A, Cossutta R, Majdan M, Damjanovska Rajcevska L, Tikly M, Nasonov EL, Steinbrink K, Herrick A, Muller-Ladner U, Dinc A, Scorza R, Sondergaard K, Indiveri F, Nielsen H, Szekanecz Z, Silver RM, Antivalle M, Espinosa IB, Garcia de la Pena Lefebvre P, Midtvedt O, Launay D, Valesini F, Tuvik P, Ionescu RM, Del Papa N, Pinto S, Wigley F, Mihai C, Sinziana Capranu M, Sunderkotter C, Jun JB, Alhasani S, Distler JH, Ton E, Soukup T, Seibold J, Zeni S, Nash P, Mouthon L, De Keyser F, Duruoz MT, Cantatore FP, Strauss G, von Mulhen CA, Pozzi MR, Eyerich K, Szechinski J, Keiserman M, Houssiau FA, Roman-Ivorra JA, Krummel-Lorenz B, Aringer M, Westhovens R, Bellisai F, Mayer M, Stoeckl F, Uprus M, Volpe A, Buslau M, Yavuz S, Granel B, Valderilio Feijo A, Del Galdo F, Popa S, Zenone T, Ricardo Machado X, Pileckyte M, Stebbings S, Mathieu A, Tulli A, Tourinho T, Souza R, Acayaba de Toledo R, Stamp L, Solanki K, Veale D, Francisco Marques Neto J, Bagnato GF, Loyo E, Toloza S, Li M, Ahmed Abdel Atty Mohamed W, Cobankara V, Olas J, Salsano F, Oksel F, Tanaseanu CM, Foti R, Ancuta C, Vonk M, Caramashi P, Beretta L, Balbir A, Chiala A, Pasalic Simic K, Ghio M, Stamenkovic B, Rednic S, Host N, Pellerito R, Hachulla E, Furst DE. Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis: results from the EULAR Scleroderma Trial and Research Group (EUSTAR) database. J Rheumatol. 2010 Jul;37(7):1488-501. doi: 10.3899/jrheum.091165. Epub 2010 Jun 15.
PubMed 20551097
Barsotti S, Stagnaro C, d'Ascanio A, Della Rossa A. One year in review 2016: systemic sclerosis. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):3-13. Epub 2016 Jul 18.
PubMed 27463613
Bellando-Randone S, Matucci-Cerinic M. Very Early Systemic Sclerosis and Pre-systemic Sclerosis: Definition, Recognition, Clinical Relevance and Future Directions. Curr Rheumatol Rep. 2017 Sep 18;19(10):65. doi: 10.1007/s11926-017-0684-2.
PubMed 28921059
Boutou AK, Pitsiou GG, Siakka P, Dimitroulas T, Paspala A, Sourla E, Chavouzis N, Garyfallos A, Argyropoulou P, Stanopoulos I. Phenotyping Exercise Limitation in Systemic Sclerosis: The Use of Cardiopulmonary Exercise Testing. Respiration. 2016;91(2):115-23. doi: 10.1159/000442888. Epub 2016 Jan 6.
PubMed 26731293
Brower LM, Poole JL. Reliability and validity of the Duruoz Hand Index in persons with systemic sclerosis (scleroderma). Arthritis Rheum. 2004 Oct 15;51(5):805-9. doi: 10.1002/art.20701.
PubMed 15478150
Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
PubMed 12831398
Cella DF, Bonomi AE. Measuring quality of life: 1995 update. Oncology (Williston Park). 1995 Nov;9(11 Suppl):47-60.
PubMed 8608056
Coulter CL, Scarvell JM, Neeman TM, Smith PN. Physiotherapist-directed rehabilitation exercises in the outpatient or home setting improve strength, gait speed and cadence after elective total hip replacement: a systematic review. J Physiother. 2013 Dec;59(4):219-26. doi: 10.1016/S1836-9553(13)70198-X.
PubMed 24287215
Crosby CA, Wehbe MA, Mawr B. Hand strength: normative values. J Hand Surg Am. 1994 Jul;19(4):665-70. doi: 10.1016/0363-5023(94)90280-1.
PubMed 7963331
de Oliveira NC, Portes LA, Pettersson H, Alexanderson H, Bostrom C. Aerobic and resistance exercise in systemic sclerosis: State of the art. Musculoskeletal Care. 2017 Dec;15(4):316-323. doi: 10.1002/msc.1185. Epub 2017 Apr 5.
PubMed 28378937
Dechman G, Scherer SA. Outcome Measures in Cardiopulmonary Physical Therapy: Focus on the Glittre ADL-Test for People with Chronic Obstructive Pulmonary Disease. Cardiopulm Phys Ther J. 2008 Dec;19(4):115-8. No abstract available.
PubMed 20467508
Duruoz MT, Poiraudeau S, Fermanian J, Menkes CJ, Amor B, Dougados M, Revel M. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996 Jul;23(7):1167-72.
PubMed 8823687
Fernandes-Andrade AA, Britto RR, Soares DCM, Velloso M, Pereira DAG. Evaluation of the Glittre-ADL test as an instrument for classifying functional capacity of individuals with cardiovascular diseases. Braz J Phys Ther. 2017 Sep-Oct;21(5):321-328. doi: 10.1016/j.bjpt.2017.06.001. Epub 2017 Jul 3.
PubMed 28711380
Ganderton L, Jenkins S, Gain K, Fowler R, Winship P, Lunt D, Gabbay E. Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension: protocol for a randomised controlled trial. BMC Pulm Med. 2011 May 23;11:25. doi: 10.1186/1471-2466-11-25.
PubMed 21600062

Want to know more?

Samantha Alegria, MsC

+55 (21) 992936572

s.gomesdealegria13@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
RecruitingPhase 1/2
A Study to Test CRT-402 in Refractory Autoimmune Disease
Autoimmune Diseases, Systemic Lupus Erythematosus

All Scleroderma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Rehabilitation in Women With Scleroderma: Effects on Pulmonary Function, Lung Ultrasound, Muscle Function, Hand Functional, Functional Capacity, and Quality of Life
ClinicalTrials.gov ID: NCT05041868
Acronym / sponsor ID: 02794918.1.0000.5259
Conditions: Scleroderma, System; Sclerosis, Muscle Strain, Physical Disability, Quality of Life, Exercise
Keywords: Scleroderma, Physical Therapy, Rehabilitation, Functional capacity, Exercise, ADL-Glittre test
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 104 participants (estimated)
Lead sponsor: Centro Universitário Augusto MottaUniversity, hospital or other
Study start: 15 Oct 2021 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 13 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Study group	Experimental	Other: TreatmentThe 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.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TreatmentAfter 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.	Other	Study group

Primary outcome

Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test) before and after the execution of the treatment plan
Time frame: twelve weeks
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.

6 secondary outcomes

Peripheral muscle function before and after the execution of the treatment plan
Time frame: twelve weeks
Cochin Hand Functional Scale (CHFS)
Time frame: 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.
Time frame: twelve weeks
Pulmonary Function Tests before and after the execution of the treatment plan
Time frame: twelve weeks
Lung ultrassound before and after the execution of the treatment plan
Time frame: twelve weeks
Disability assessment using the Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) before and after the execution of the treatment plan
Time frame: twelve weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
Background: PubMed 25233870Alhajeri H, Hudson M, Fritzler M, Pope J, Tatibouet S, Markland J, Robinson D, Jones N, Khalidi N, Docherty P, Kaminska E, Masetto A, Sutton E, Mathieu JP, Ligier S, Grodzicky T, LeClercq S, Thorne C, Gyger G, Smith D, Fortin PR, Larche M, Baron M. 2013 American College of Rheumatology/European League against rheumatism classification criteria for systemic sclerosis outperform the 1980 criteria: data from the Canadian Scleroderma Research Group. Arthritis Care Res (Hoboken). 2015 Apr;67(4):582-7. doi: 10.1002/acr.22451.
Background: PubMed 20551097Avouac J, Walker U, Tyndall A, Kahan A, Matucci-Cerinic M, Allanore Y; EUSTAR; Miniati I, Muller A, Iannone F, Distler O, Becvar R, Sierakowsky S, Kowal-Bielecka O, Coelho P, Cabane J, Cutolo M, Shoenfeld Y, Valentini G, Rovensky J, Riemekasten G, Vlachoyiannopoulos P, Caporali R, Jiri S, Inanc M, Zimmermann Gorska I, Carreira P, Novak S, Czirjak L, Oliveira Ramos F, Jendro M, Chizzolini C, Kucharz EJ, Richter J, Cozzi F, Rozman B, Mallia CM, Gabrielli A, Farge D, Kiener HP, Schoffel D, Airo P, Wollheim F, Martinovic D, Trotta F, Jablonska S, Reich K, Bombardieri S, Siakka P, Pellerito R, Bambara LM, Morovic-Vergles J, Denton C, Hinrichs R, Van den Hoogen F, Damjanov N, Kotter I, Ortiz V, Heitmann S, Krasowska D, Seidel M, Hasler P, Van Laar JM, Kaltwasser JP, Foeldvari I, Juan Mas A, Bajocchi G, Wislowska M, Pereira Da Silva JA, Jacobsen S, Worm M, Graniger W, Kuhn A, Stankovic A, Cossutta R, Majdan M, Damjanovska Rajcevska L, Tikly M, Nasonov EL, Steinbrink K, Herrick A, Muller-Ladner U, Dinc A, Scorza R, Sondergaard K, Indiveri F, Nielsen H, Szekanecz Z, Silver RM, Antivalle M, Espinosa IB, Garcia de la Pena Lefebvre P, Midtvedt O, Launay D, Valesini F, Tuvik P, Ionescu RM, Del Papa N, Pinto S, Wigley F, Mihai C, Sinziana Capranu M, Sunderkotter C, Jun JB, Alhasani S, Distler JH, Ton E, Soukup T, Seibold J, Zeni S, Nash P, Mouthon L, De Keyser F, Duruoz MT, Cantatore FP, Strauss G, von Mulhen CA, Pozzi MR, Eyerich K, Szechinski J, Keiserman M, Houssiau FA, Roman-Ivorra JA, Krummel-Lorenz B, Aringer M, Westhovens R, Bellisai F, Mayer M, Stoeckl F, Uprus M, Volpe A, Buslau M, Yavuz S, Granel B, Valderilio Feijo A, Del Galdo F, Popa S, Zenone T, Ricardo Machado X, Pileckyte M, Stebbings S, Mathieu A, Tulli A, Tourinho T, Souza R, Acayaba de Toledo R, Stamp L, Solanki K, Veale D, Francisco Marques Neto J, Bagnato GF, Loyo E, Toloza S, Li M, Ahmed Abdel Atty Mohamed W, Cobankara V, Olas J, Salsano F, Oksel F, Tanaseanu CM, Foti R, Ancuta C, Vonk M, Caramashi P, Beretta L, Balbir A, Chiala A, Pasalic Simic K, Ghio M, Stamenkovic B, Rednic S, Host N, Pellerito R, Hachulla E, Furst DE. Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis: results from the EULAR Scleroderma Trial and Research Group (EUSTAR) database. J Rheumatol. 2010 Jul;37(7):1488-501. doi: 10.3899/jrheum.091165. Epub 2010 Jun 15.
Background: PubMed 27463613Barsotti S, Stagnaro C, d'Ascanio A, Della Rossa A. One year in review 2016: systemic sclerosis. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):3-13. Epub 2016 Jul 18.
Background: PubMed 28921059Bellando-Randone S, Matucci-Cerinic M. Very Early Systemic Sclerosis and Pre-systemic Sclerosis: Definition, Recognition, Clinical Relevance and Future Directions. Curr Rheumatol Rep. 2017 Sep 18;19(10):65. doi: 10.1007/s11926-017-0684-2.
Background: PubMed 26731293Boutou AK, Pitsiou GG, Siakka P, Dimitroulas T, Paspala A, Sourla E, Chavouzis N, Garyfallos A, Argyropoulou P, Stanopoulos I. Phenotyping Exercise Limitation in Systemic Sclerosis: The Use of Cardiopulmonary Exercise Testing. Respiration. 2016;91(2):115-23. doi: 10.1159/000442888. Epub 2016 Jan 6.
Background: PubMed 15478150Brower LM, Poole JL. Reliability and validity of the Duruoz Hand Index in persons with systemic sclerosis (scleroderma). Arthritis Rheum. 2004 Oct 15;51(5):805-9. doi: 10.1002/art.20701.
Background: PubMed 12831398Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes. 2003 Jun 9;1:20. doi: 10.1186/1477-7525-1-20.
Background: PubMed 8608056Cella DF, Bonomi AE. Measuring quality of life: 1995 update. Oncology (Williston Park). 1995 Nov;9(11 Suppl):47-60.
Background: PubMed 24287215Coulter CL, Scarvell JM, Neeman TM, Smith PN. Physiotherapist-directed rehabilitation exercises in the outpatient or home setting improve strength, gait speed and cadence after elective total hip replacement: a systematic review. J Physiother. 2013 Dec;59(4):219-26. doi: 10.1016/S1836-9553(13)70198-X.
Background: PubMed 7963331Crosby CA, Wehbe MA, Mawr B. Hand strength: normative values. J Hand Surg Am. 1994 Jul;19(4):665-70. doi: 10.1016/0363-5023(94)90280-1.
Background: PubMed 28378937de Oliveira NC, Portes LA, Pettersson H, Alexanderson H, Bostrom C. Aerobic and resistance exercise in systemic sclerosis: State of the art. Musculoskeletal Care. 2017 Dec;15(4):316-323. doi: 10.1002/msc.1185. Epub 2017 Apr 5.
Background: PubMed 20467508Dechman G, Scherer SA. Outcome Measures in Cardiopulmonary Physical Therapy: Focus on the Glittre ADL-Test for People with Chronic Obstructive Pulmonary Disease. Cardiopulm Phys Ther J. 2008 Dec;19(4):115-8. No abstract available.
Translation, cultural adaptation and reproducibility of the Cochin Hand Functional Scale questionnaire for BrazilLink provided by the sponsor.
Pereira CAC. Espirometria. J Bras Pneumol. 2002; 28(Supl. 3): 1-82.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Scleroderma

RecruitingPhase 1
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
RecruitingPhase 1/2
A Study to Test CRT-402 in Refractory Autoimmune Disease
Autoimmune Diseases, Systemic Lupus Erythematosus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samantha Alegria, MsC contact

+55 (21) 992936572

s.gomesdealegria13@gmail.com

Agnaldo Lopes, PhD contact

+55 (21) 25762030

agnaldolopes.uerj@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Treatment in people with Scleroderma and System; Sclerosis, run by Centro Universitário Augusto Motta at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Samantha Alegria, MsC (+55 (21) 992936572, s.gomesdealegria13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test) before and after the execution of the treatment plan (time frame: twelve weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05041868, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.