Individualized Home-based Exercise Program for Patient With Systemic Sclerosis.
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

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.
    

Detailed description: 
      This will be a randomized, controlled, six months parallel group study. The flow chart of the
      study is reported in table 1. Participants initially will undergo 2 days of screening and
      testing. During the first visit patients will sign an informed consent, will undergo clinical
      assessment, pulmonary function testing, measurement of anthropometric data and body
      composition by bioimpedentiometry. They will perform a graded exercise test on a
      cycloergometer and will complete questionnaires to assess HRQoL (short form-36, SF-36) and
      functional abilities (health assessment questionnaire disability index, HAQ-DI). During the
      second visit, the participants will carry out the hand mobility in scleroderma test (HAMIS),
      six minutes walking test (6MWT), will undergo measurements of quadriceps and biceps strength,
      and handgrip test. After completion of testing and screening, patients who will meet the
      selection criteria will be randomly assigned to one of two groups 1) home-care rehabilitation
      group (HCRG); 2) control group (CG). The first group will begin a six months program of
      exercise training. The patients of the second group will be given generic recommendations to
      increase physical activity.

      The patients in the first group, during a session in our outpatient clinic, will be
      instructed by a physiotherapist how to perform the physical exercise program at home. In
      particular, they will learn how to use the stationary bike and how to perform the exercises
      for upper limbs. Furthermore, the patient of the first group will be instructed how to fill
      in a card in which they will record the exercises performed daily. Throughout the first three
      months of the training period, the patients received a phone call from a physiotherapist once
      monthly, during which the adherence to exercise program will be reinforced. Particularly, it
      will be asked about the adherence to and the acceptance of exercise program, and the presence
      of side effects. Also, the control group will receive a phone call with the same schedule,
      but only in order to evaluate health status and to give a general recommendation about the
      positive effect of the aerobic exercise. From the third to the sixth month, both groups will
      not receive a monthly call, in order to evaluate the adherence to the program in the absence
      of supervision.

      After 3 and 6 months, the subjects will undergo a complete 2 days of testing, using the same
      schedule described for a baseline.

      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.

      A stationary cycle (Energetics ct220p, Neomark Sarl, Luxembourg) will be given to each
      patient for lower limb training. Each session will consist of three phases. In the first one,
      the patient will pedal for 5 minutes without inserting the brake. In the second phase, the
      patient will be instructed to set the brake at a load equal to 60% of the watts achieved at
      the peak of the maximal ergocycle exercise test. This phase consists in two periods of
      fifteen minutes divided by recovery interval of three minutes. It will be followed by five
      minutes of cool-down without load. The frequency of pedalling will be about 60 rotation/min
      during the second phase and less than 50 during the other phases.

      For upper limbs training the patients will perform ten repetitions for three times that
      consists in lifting and lowering repeatedly a weight from the waist to the shoulders,
      alternating periods of exercise and three minutes of rest. The load will be calculated as the
      60% of predicted 1-RM. Warm up and stretching of upper limbs, shoulders and neck will be
      performed before and after each exercise session respectively.

      For the first two weeks, for both types of exercises of the program, the load will be reduced
      by 20%.

      For finger stretching to the patients will be given written and illustrated instructions on
      self-administered exercises, and 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 whether the tasks were complete, partially or not executed which corresponds a
      score of 1, 0.5, 0 respectively.

      The attendance rate at the training session will be calculated by the ratio between the
      amount of the score obtained from the diary and the scheduled sessions multiplied for 100.
    

Intervention name(s): Home-care rehabilitation group (HCRG)
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): Experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind RCT with two parallel group
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Systemic sclerosis; Home based rehabilitation; Quality of life; Hand mobility; Exercise capacity