Individualized Home-based Exercise Program for Patient With Systemic Sclerosis.

NCT03614208 | Completed DMC

• 1 other identifier: ESSE2016
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic sclerosis (SSc) is an uncommon chronic rheumatic disease with an unknown cause and unpredictable course. The inability, in addition to easy fatigability, starts a vicious circle that leads to a fast deterioration of physical conditions that cause a reduction of aerobic exercise capacity and, consequently, of health-related quality of life (HRQoL). Aerobic exercise has already been shown to be safe and effective in improving exercise capacity and HRQoL of patients with chronic cardiovascular and pulmonary diseases. However, few studies have evaluated the role of specific exercise programs on the muscular impairment in SSc. Nevertheless, the results obtained in preliminary reports are promising, and, for these reasons, the management of muscular impairment in SSc could include an appropriate rehabilitation program besides pharmaceutical and surgical treatments. The primary aim of this study will be to evaluate the effect of an individualized exercise program performed at home on aerobic capacity evaluated by 6 minutes walking test. Secondary aims will be to evaluate: 1- VO2max, measured by cardiopulmonary test; 2- the effect of the same program on the muscular strength of upper and lower limbs; 3- the efficacy of a self-administered stretching program for finger joint motion. Secondary aims will be also 1-to ascertain whether a comprehensive exercise program may affect, besides physical function, HRQoL; 2- and to evaluate the adherence during two periods of three months, one whit and one without supervision and reinforcement by a phone call. All the patients with a diagnosis of SSc, according to the criteria of American College of Rheumatology (ACR), who attended the Rheumatologic outpatient clinic of our institution will be evaluated in order to participate in the rehabilitation program. The pneumological examination and two days of screening and testing will take place at the outpatient's clinic of Respiratory Medicine and Sport of our institution.

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis; Home based rehabilitation; Quality of life; Hand mobility; Exercise capacity

Outcome Measures

Primary Outcomes (1)

• Six minute walking test

  Evaluate aerobic capacity

  Up to six months

Secondary Outcomes (9)

• Maximum oxygen consumption (VO2max)

  Up to six months

• Handgrip strength

  Up to six months

• Muscular strength of upper limbs

  Up to six months

• One repetition maximum (1-RM) of biceps strength

  Up to six months

• Muscular strength of lower limbs

  Up to six months

Study Arms (2)

Home-care rehabilitation group (HCRG)

EXPERIMENTAL

The home-based exercise program consists of aerobic exercise on a stationary bike, muscular endurance training of the upper limb and stretching exercises for finger joint motion. The exercise on the stationary bike and muscular endurance training will be performed on alternate days, three times a week. For finger stretching the patients will be directed to perform it every day, both in the morning and in the evening. During the rehabilitation period, the patients will report each day on a diary for each type of exercise. They received a phone call monthly, only for the first 3 months, to encourage them about the adherence and investigate any problems with the exercise program.

Behavioral: Home-care rehabilitation group (HCRG)

Control group

NO INTERVENTION

Control group was encouraged to perform the generic aerobic physical activity at the baseline. Also, they received a monthly phone call, only for the first 3 months, to encourage them about the importance of doing aerobic exercise.

Interventions

Home-care rehabilitation group (HCRG) BEHAVIORAL

The exercise program consists of aerobic exercise on a stationary bike, muscular endurance training of the upper limb and stretching exercises for finger joint motion. The exercise on the stationary bike and muscular endurance training will be performed on alternate days, three times a week.

Also known as: Experimental group

Home-care rehabilitation group (HCRG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of SSc according to the criteria of ACR
• no hospitalizations in the previous 3 months
• no change in anti-rheumatic treatment in the previous 3 months
• signed informed consent

You may not qualify if:

• heart failure staging in classes III or IV of New York Heart Association (NYHA)
• pulmonary hypertension, defined by echocardiogram as a right ventricular systolic pressure ≥ 45mmHg
• vital capacity (VC) ≤ 50% or diffusion lung capacity of carbon monoxide (DLCO) ≤ 30% of predicted values.
• renal failure defined as a calculated glomerular filtration rate (GFR) \< 30ml/min, in agreement with the staging of International Federation of National Kidney Foundations
• inability to perform the rehabilitation program due to skeletal-muscle impairments or other illnesses
• pregnancy or planned pregnancy in the next 6 months
• psychiatric disorders that prevent collaboration and adherence at the rehabilitation the program, including drug abuse
• involvement in ongoing aerobic or anaerobic exercise programs
• Drop out criteria:
• the demonstration of ischemic heart disease after cardiopulmonary exercise testing performed at baseline
• need to change the dosage or interruption of prostanoids used in the treatment of SSc during the 6 months of the treatment

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera, SSO respiratory pathophysiology Unit, Verona

Verona, Italy/Verona, 37134, Italy

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Marcello Ferrari, Professor

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single blind RCT with two parallel group

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 3, 2018
• Study Start: February 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

IT (1)