Exploring the Effects of a Combined Exercise Programme on Pain and Fatigue Outcomes in People With Systemic Sclerosis: A Large Multi-centre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Fatigue Assessment
研究概览
简要总结
Raynaud's phenomenon and digital ulceration are two of the most common disease manifestations leading to digital and/or toe pain in systemic sclerosis (SSc). In addition to pain, fatigue has been identified as a key stressor and the most prevalent and debilitating symptom of SSc. Both, affect significantly quality of life (QoL) domains. Pharmacological therapeutic strategies have not been proved sufficiently effective in the management of SSc-induced pain and fatigue. Evidently the effectiveness of non-pharmacological interventions (e.g., exercise, cognitive behavioural therapy) is limited, although for some of them (i.e., exercise) evidence is promising. As yet, the effects of a feasible, long-term, tailored exercise programme on pain and fatigue in people with SSc have not been explored. Therefore, the investigators propose a multicentre (n=5) research clinical trial to assess the effect of a previously established, supervised 12-week combined (aerobic and resistance training) exercise programme on pain and fatigue. The 26-month study will recruit 180 people with SSc that will be allocated randomly to two groups. Group A will perform the exercise programme parallel to standard care and Group B will receive the standard care alone. All participants will be followed for 24-weeks. Results will inform clinical practice and may improve QoL for people with SSc.
详细描述
Background Pain in SSc originates from disease activity and is one of the most important patient-reported outcomes in rheumatology. It is estimated that up to 83% of people with SSc have significant pain. Raynaud's phenomenon (RP) and digital ulceration are two of the most common disease manifestations leading to digital and/or toe pain. Greater skin thickening is related to worse pain. SSc-related pain has been linked with numerous QoL domains, including mental health, physical health, and societal functioning (e.g., depression; with a strong relation between depression and pain, sleep, disability, fatigue, employment status. Given these personal, social, and financial implications for people with SSc, pain management should be one of the main goals of SSc-patient care. However, there is a lack of interventional research on SSc pain.
In addition to pain, fatigue has been identified as the main stressor and the most prevalent and debilitating symptom of SSc. Similar to pain, fatigue leads to a significant impairment of QoL, including physical disability, working, and parenting. In SSc, there is also a strong relation between fatigue and depression.
Pharmacological therapeutic strategies have been adopted in the management of pain and fatigue in SSc without being sufficiently effective. The evidence of the effectiveness of non-pharmacological interventions (e.g., the effects of exercise on SSc pain and fatigue) is limited, but promising. Engagement in regular exercise is associated with lower pain intensity and interference in people with SSc. Higher daily physical activity levels are associated with improved skin microvascular function in type 2 diabetes (a clinical condition with increased vasculopathy similar to that observed in SSc). This might explain partly why RP's pain is observed less in toes (as lower limbs are the most commonly used body part for daily activities) when compared to fingers. Thus, our focus would be mainly on digital pain in hands. Physically active people with SSc have lower levels of fatigue compared to inactive individuals. Moreover, evidence (e.g., one-to-one semi-structured interviews) from our recently completed feasibility study suggests that people with SSc feel more energetic and stronger following a combined (e.g., aerobic and resistance training) exercise programme, improving also their fitness and social life. Thus, a feasible, safe, long-term exercise programme for people with SSc that will improve pain and fatigue is warranted. Therefore, and being supported by published evidence, the investigators propose a multicentre RCT to assess the effect of such an exercise programme on pain and fatigue in this clinical population.
Research Objectives
- To investigate the effects of the proposed intervention on digital pain and fatigue of people with SSc.
- To investigate the effects of the proposed intervention on QoL, depression, cardiorespiratory fitness, strength of people with SSc.
- To investigate the effects of the proposed intervention on the digital structural vascular changes in people with SSc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Systemic Sclerosis according to the 2013 ACR/EULAR criteria experiencing Raynaud's phenomenon
- •Age over 18 years old
- •Ability to perform the prescribed exercise regime
排除标准
- •Active disease-related exacerbations (e.g., active digital ulcers)
- •Change of medical treatment (I.e., medical treatment which is related with the vascular function and blood flow such as calcium channel blockers and vasodilators) within the last 3 months (however, potential participants will be able to take part following that period)
- •Advanced pulmonary involvement (e.g., pulmonary arterial hypertension)
- •New York Heart Association class 3 or 4
- •Inability to exercise
- •Current pregnancy
研究组 & 干预措施
Exercise group
The exercise group will perform a supervised combined (e.g., aerobic and resistance training) 12-week exercise programme, twice per week adjunct to the patient's standard care.
干预措施: Exercise programme (Other)
Control group
The control group will not perform the exercise programme and will receive only the standard care.
结局指标
主要结局
Fatigue Assessment
时间窗: 6-month follow up
Fatigue in people with SSc will be assessed using the functional assessment of chronic illness therapy-fatigue (FACIT-F) which has also been utilised in studies assessing fatigue in people with SSc. Participants will be requested to self-complete this 40-item questionnaire which will assess fatigue and its impact on daily activities and function. FACIT-F is formatted in a Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). All items contribute to the sum score with equal weight. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
Pain Assessment (Overall Pain)
时间窗: 6-month follow up
Overall pain will be assessed using the visual analogue scale (VAS) included in scleroderma health assessment questionnaire (SHAQ; VAS-SHAQ). VAS-SHAQ is consisted of a 15-cm which is converted to a continuous scale from 0 to 3 (1cm = 0.2 points on the VAS). For the VAS-SHAQ scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.
Pain Assessment (Digital Pain)
时间窗: 6-month follow up
Digital pain will be assessed using a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The pain VAS will be comprised of a vertical line, usually 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 100). For the digital VAS scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.
Pain Assessment (Overall Pain)
时间窗: 3-month follow up
Overall pain will be assessed using the visual analogue scale (VAS) included in scleroderma health assessment questionnaire (SHAQ; VAS-SHAQ). VAS-SHAQ is consisted of a 15-cm which is converted to a continuous scale from 0 to 3 (1cm = 0.2 points on the VAS). For the VAS-SHAQ scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.
Pain Assessment (Digital Pain)
时间窗: 3-month follow up
Digital pain will be assessed using a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The pain VAS will be comprised of a vertical line, usually 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 100). For the digital VAS scale participants will be requested to self-complete the pain by placing a line perpendicular to the VAS line at the point that represents their overall and digital pain intensity.
Fatigue Assessment
时间窗: 3-month follow up
Fatigue in people with SSc will be assessed using the functional assessment of chronic illness therapy-fatigue (FACIT-F) which has also been utilised in studies assessing fatigue in people with SSc. Participants will be requested to self-complete this 40-item questionnaire which will assess fatigue and its impact on daily activities and function. FACIT-F is formatted in a Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). All items contribute to the sum score with equal weight. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
次要结局
- Quality of life questionnaire(6-month follow up)
- Depression scale questionnaire(6-month follow up)
- Microvascular assessment(6-month follow up)
- Peak oxygen uptake test on an arm crank ergometer(6-month follow up)
- Handgrip strength test(6-month follow up)
- Biceps curl endurance test(6-month follow up)
- Microvascular assessment(3-month follow up)
- Quality of life questionnaire(3-month follow up)
- Depression scale questionnaire(3-month follow up)
- Peak oxygen uptake test on an arm crank ergometer(3-month follow up)
- Handgrip strength test(3-month follow up)
- Biceps curl endurance test(3-month follow up)