跳至主要内容
临床试验/NCT03058887
NCT03058887已完成不适用

Investigating the Effectiveness and Feasibility of Exercise on Microcirculatory Parameters and Quality of Life in Systemic Sclerosis Patients Experiencing Raynaud's Phenomenon.

Sheffield Hallam University4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
4
主要终点
Part I (Pilot study): Microcirculation in the digital area

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm cranking

Experimental

exercising for 3 months twice per week.

干预措施: Exercise intervention - arm cranking (Other)

Cycling

Experimental

exercising for 3 months twice per week.

干预措施: Exercise intervention - Cycling (Other)

Control group

No Intervention

No exercise intervention.

结局指标

主要结局

Part I (Pilot study): Microcirculation in the digital area

时间窗: 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): Assessment of Quality of life

时间窗: 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 II (Feasibility study): Feasibility of a combined exercise protocol (aerobic with resistance training).

时间窗: 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.

次要结局

  • Part I (Pilot study): Quality of life(12 months)
  • Part I (Pilot study): Enjoyment levels and acceptability of exercise(12 months)
  • Part II (Feasibility): Microcirculation in the digital area(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验