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The Effects of Exercise in Patients With Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT03058887
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Hallam University

Tracking Information
First Submitted Date  ICMJE October 13, 2016
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Part I (Pilot study): Microcirculation in the digital area [ Time Frame: 12 months ]
    Microcirculation will be assessed via the combination of iontophoresis and laser doppler fluximetry in order to assess the microvascular reactivity pre and post the exercise intervention in the digital area.
  • Part II (Feasibility study): Feasibility of a combined exercise protocol (aerobic with resistance training). [ Time Frame: 12 months ]
    The feasibility of the exercise protocol will be assessed via the acceptability of the exercise protocol which will be measured with certain questionnaires (task self efficacy, enjoyment levels and engagement levels), individual experiences from the exercise sessions (interviews) and compliance criteria (e.g. completion of > 75% of the scheduled sessions and/or percentage of dropouts). All these measures will be aggregated in order to conclude whether a combined exercise is feasible to be implemented in patients with systemic sclerosis.
  • Part II (Feasibility study): Assessment of Quality of life [ Time Frame: 12 months ]
    The quality of life will be assessed through a modified version of EQ-5D-5L questionnaire, a 6 minute-walking test that will assess the functional capacity to perform daily activities and individual experiences (interviews).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03058887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Part I (Pilot study): Quality of life [ Time Frame: 12 months ]
    The quality of life will be assessed through a modified version of EQ-5D-5L questionnaire, a 6 minute-walking test that will assess the functional capacity to perform daily activities and individual experiences (interviews).
  • Part I (Pilot study): Enjoyment levels and acceptability of exercise [ Time Frame: 12 months ]
    The acceptability of the exercise protocol and enjoyment levels which will be assessed via certain questionnaires (task self efficacy, enjoyment levels and engagement levels)
  • Part II (Feasibility): Microcirculation in the digital area [ Time Frame: 12 months ]
    Microcirculation will be assessed via the combination of iontophoresis and laser doppler fluximetry in order to assess the microvascular reactivity pre and post the exercise intervention in the digital area.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Exercise in Patients With Systemic Sclerosis
Official Title  ICMJE Investigating the Effectiveness and Feasibility of Exercise on Microcirculatory Parameters and Quality of Life in Systemic Sclerosis Patients Experiencing Raynaud's Phenomenon.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Systemic Sclerosis
  • Raynaud's Phenomenon
  • Quality of Life
Intervention  ICMJE
  • Other: Exercise intervention - Cycling
    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).
  • Other: Exercise intervention - arm cranking
    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).
Study Arms  ICMJE
  • Experimental: Arm cranking
    exercising for 3 months twice per week.
    Intervention: Other: Exercise intervention - arm cranking
  • Experimental: Cycling
    exercising for 3 months twice per week.
    Intervention: Other: Exercise intervention - Cycling
  • No Intervention: Control group
    No exercise intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Patients diagnosed with Limited Cutaneous Systemic Sclerosis according to the 2013 ACR/EULAR criteria experiencing Raynaud's phenomenon.
  • Men or women aged 18-80 years old.
  • Disease duration between 1 to 10 years.
  • Patients should be able to perform exercise. Exclusion criteria
  • Patients with advanced pulmonary arterial hypertension or interstitial lung disease.
  • Patients who are diagnosed with another inflammatory condition.
  • Patients presenting myositis with proximal muscle weakness.
  • Patients with New York Heart Association class 3 or 4.
  • Current smokers or people who stopped smoking within 4 weeks of health screening.
  • Women who are currently pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03058887
Other Study ID Numbers  ICMJE IRAS: 68096
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheffield Hallam University
Study Sponsor  ICMJE Sheffield Hallam University
Collaborators  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Investigators  ICMJE Not Provided
PRS Account Sheffield Hallam University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP