Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot Study
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

Summary: 
      The hypothesis is that intensive aerobic and endurance muscle training is safe and beneficial
      in patients with systemic sclerosis and concurrent interstitial lung disease.

      The purpose of the study is to examine the effect of an eight week intensive aerobic exercise
      and muscle endurance training program for patients with systemic sclerosis and 50-100 % of
      forced vital capacity.

      A single subject experimental design with repeated systematic measures during a six week
      A-phase (baseline period) and an eight week B-phase (intervention period) was used. Physical
      capacity (six minute walk test), aerobic capacity (submaximal treadmill test) and muscle
      endurance in shoulder and hip flexion (Functional Index 2) are assessed every other week
      throughout the 14 week study. Activity limitation (Health Assessment Questionnaire), quality
      of life (Short Form 36), Raynaud, Fatigue and Global Health during the recent week (Visual
      Analogue Scales) are assessed at weeks 0, 6, 14. The exercise program includes aerobic
      exercise corresponding to 15 on the Borg RPE scale (strenuous) and muscular endurance
      training three times/week.
    

Detailed description: 
      The purpose of the study is to examine the effect of an eight week intensive aerobic exercise
      and muscle endurance training program for patients with systemic sclerosis and 50-100 % of
      forced vital capacity.

      As systemic sclerosis is a very rare condition a Single Subject Experimental Design (SSED)
      was used including a 6-week non-interventional A-phase where patients are assessed
      systematically followed by an 8-week interventional B-phase where patients exercise three
      days a week with continued systematic assessments. According to the 2-standard deviation (2
      SD) band analysis, statistical analysis were performed for each patient individually.
      Accordingly, a statistically significant change was detected if two consecutive assessments
      in the B-phase exceeded the 2 standard deviations (SD) of the mean of the A-phase.

      Patients were recruited from an ongoing study at the Karolinska University Hospital with the
      purpose to screen all patients with systemic sclerosis in Stockholm for cardiovascular
      disease. All patients meeting the inclusion criteria were invited to participate in this
      exercise study.

      Assessments:

      The six minute walking test was used to assess physical capacity. A submaximal treadmill test
      was used to estimate oxygen uptake in ml/kg x min. Muscle endurance was assessed by the
      Functional Index 2 registering the number of correct performed repetitions in 7 muscle
      groups. Pain, Raynaud's Phenomenon, fatigue and global disease impact on general well-being
      was assessed by the Visual Analogue scale (VAS), 0-100. Limitations in activities of daily
      living were assessed using the Health Assessment Questionnaire and the SF-36 was included to
      assess perceived health.

      The Exercise program:

      The program starts with a 10-minute warm-up session with biking at an intensity corresponding
      to perceived light exertion (10 on the Borg RPE, 6-20 scale). Thereafter, the load is
      increased to reach an intensity corresponding to perceived heavy exertion (15 on the Borg RPE
      scale) for an additional 15 minutes. During the last five minutes of the biking session, the
      loads are reduced to an intensity corresponding to light exertion. Heart rate was is recorded
      with a pulse watch (RS100 Polar) and peripheral saturation recorded with a heart rate
      oximeter (Wristox 3100 Nonin Medical). During the first weeks patients start on lower leads
      and increasing to the goal intensity. After the biking exercises, the participants perform
      repetitive dynamic muscle resistance training with the goal to achieve as many repetitions as
      possible in shoulder flexion and in hip flexion.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Intensive aerobic and muscle endurance exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic sclerosis; Exercise; Physical capacity; Aerobic capacity; Muscle function; Fatigue