The Effects of Exercise in Patients With Systemic Sclerosis
Condition: Systemic Sclerosis; Raynaud's Phenomenon; Quality of Life
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

Summary: 
      Systemic sclerosis (SSc) is a multisystem connective tissue disease characterised by vascular
      abnormalities and fibrosis, including those of the skin and can be categorised as either
      Limited cutaneous scleroderma or Diffuse cutaneous scleroderma. It is estimated that more
      than 90% of patients with SSc experience Raynaud's phenomenon (RP) at regular intervals
      during the course of their disease. Approximately 50% of patients with SSc develop severe
      digital ischaemia and/or ulceration which seems to be painful, difficult to heal, susceptible
      to infections and heavily influences quality of life and increases SSc-related disability.

      Medical treatment is commonly used as an effective first line approach in the NHS policy when
      uncontrolled RP attacks emerge. However, considering the short-term side effects (oedema,
      headaches, heart palpitations, dizziness and constipation) but also the long-term side
      effects of nifedipine (heart dysfunction and increased cardiovascular risk) as well as the
      financial cost of this approach, alternative approaches with less side effects and less cost
      implications are warranted.

      An alternative approach would be to implement a programme of therapeutic exercise that would
      be suitable for this patient group. To the investigators knowledge the efficacy of exercise
      on microcirculation in RP has not been previously examined. In this regard, high intensity
      interval training (HIIT) has come to prominence over the last years for its effectiveness in
      inducing greater improvements in vascular function than moderate intensity continuous
      training. Due to the variation in HIIT protocols evidence is limited to support which
      protocol is the most effective in SSc patients. Moreover, it should be noted that the chief
      aim of the research project is to encourage long-term adherence to physical activity and
      rehabilitation programmes in these patients which might be beneficial for the vascular
      function. A short HIIT protocol (30seconds/passive recovery) may elicit more favourable
      patient reported satisfaction /enjoyment levels compared to other longer exercise duration
      protocols. A short HIIT protocol (30seconds/passive recovery) has demonstrated to be well
      tolerated, preferred protocol with a low perception of effort, patient comfort and with a
      longer time spent at high percentage of V̇O2peak than a longer HIIT protocol with active
      recovery phases in chronic heart failure patients. More recent evidence supports this notion;
      when enjoyment levels in an overweight/obese cohort were examined after a short HIIT
      protocol.

      Although it is known that HIIT is capable to improve vascular function and potentially the
      microcirculatory parameters, evidence is scarce regarding the mode of exercise that will be
      more effective on digital microcirculation where the RP attacks are present in SSc patients.
      Assumptions could be made that utilising an upper-body exercise would potentially be more
      beneficial for the digital microcirculation rather than lower-body exercise where the working
      muscles promote the blood flow in the lower limbs. Hence, the differential effects that may
      occur by the upper- and lower-limb exercise on the digital microcirculation in SSc patients
      should be examined.

      Resistance training (RT) alone has shown significant improvements in the function of the
      vasculature; moreover, a combination of aerobic and RT have shown both in the past and
      recently important enhances in the vascular function and microcirculation. However, the
      limited number of studies have investigated the effects of RT on vasculature bespeaks a lack
      of concrete evidence. Moreover, to the investigators knowledge the effects of combined
      exercise (RT and aerobic exercise) utilising a HIIT protocol and RT on microcirculation has
      yet to be examined.

      Aims:

      The primary aim of the present study is to examine the feasibility of exercise in patients
      with Systemic Sclerosis experiencing Raynaud's Phenomenon.
    


Intervention name(s): Exercise intervention - Cycling; Exercise intervention - arm cranking
Intervention type(s): Other; Other
Intervention description(s): The patients that will be randomly allocated to the exercise group - cycling will be requested to perform an exercise session on a cycle ergometer. Each training will be consisted of high intensity interval training for 30 minutes (30s 100% PPO/ 30s passive recovery) twice per week for 3 months. Patients will perform two visits for the baseline measurements prior the exercise intervention by repeating them at the end of the exercise intervention (follow up measurements).; The patients that will be randomly allocated to the exercise group - arm cranking will be requested to perform an exercise session on an arm crank ergometer. Each training will be consisted of high intensity interval training for 30 minutes (30s 100% PPO/ 30s passive recovery) twice per week for 3 months. Patients will perform two visits for the baseline measurements prior the exercise intervention by repeating them at the end of the exercise intervention (follow up measurements).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: High Intensity Interval Training; Exercise; Microcirculation