Early Initiated Individualized Physical Training in Newly Diagnosed Multiple Myeloma Patients; Effects on Physical Function, Physical Activity, Quality of Life, Pain, and Bone Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in isometric knee extension strength measured by handhold dynamometer
研究概览
简要总结
The overall aim is to examine whether early initiated, individualized exercise training in patients newly diagnosed with multiple myeloma, irrespective of age and current performance status, will be beneficial for the patients´physical function, level of physical activity and quality of life, pain and bone disease.
The investigators will examine the effect of supervised in-hospital exercise training sessions combined with home-based exercise training, initiated at time of diagnosis. The outcomes of interest are physical function, level of physical activity, QOL, pain and bone disease.
Furthermore, to describe the disease in patients with newly diagnosed MM in relation to physical function, level of physical activity, QOL, pain and bone condition at time of diagnosis.
The investigators hypotheses are:
- Individualized exercise starting at time of diagnosis will have positive effects on physical function, physical activity, QOL and pain.
- Individualized exercise starting at time of diagnosis will have positive effects on bone disease (bone markers), bone mineral density (BMD) and lean body mass.
- A higher level of physical function is associated with a higher level of physical activity, less pain, better QOL, and higher BMD and lean body mass.
详细描述
Background Physical exercise for haematological patients is a relevant complementary treatment, including in patients with multiple myeloma (MM) (Jones 2013). In hematological cancer, exercise is feasible, safe and beneficial in numerous aspects (aerobic capacity, muscle strength, quality of life (QOL), fatigue, psychosocial wellbeing, treatment-related symptoms and body composition, before, during and after stem cell transplantation (Persoon 2013; Haren 2013). Still the evidence for the value of exercise in hematological diseases is sparse, in general and to specific diagnoses (Jones 2013; Fong 2014; Liu 2009). Patients with MM may differ from other hematological diseases, by poorer functional status due to skeletal related pain, affected QOL and immune function, but also in return to work and in risk of disability pension, and furthermore physical performance and the time of being physical active is diminished throughout the treatment course and patients do not meet physical activity guidelines (Coleman 2004; Jones 2004; Craike 2013). Hence, there is a need to examine the effect of exercise to be able to give evidence based recommendations on exercise in MM patients.
In Denmark, 320 patients are diagnosed with MM annually. The median age at diagnosis is 68-71 years, and the incidence is increasing with age. The prevalence increases due to the aging population and improved survival because of improvement in medical treatment (Kyle 2007; Sihori 2006 & 2004; Alexander 2007; Kumar 2008 & 2014). Typically, the patient presents with bone pain, anaemia, renal failure, recurrent infections, or for some patients it is detected by chance through screening of blood or urine. Bone pain is caused by osteolytic destructions which also may lead to pathological fractures.
When diagnosed, most patients (80%) will have symptomatic disease and will need start treatment. The medical treatment for MM has two aims. Firstly, anti-myeloma systemic therapy aims at reducing tumor burden and to prolong disease free survival, and overall survival, and secondly, supportive care aims at preventing serious morbidity from disease complications. Younger patients (<65-70 year) are treated with high dose chemotherapy with stem cell support (HDT). Elderly patients receive less intensive, yet still effective treatments that include novel agents (bortezomib, thalidomide). Painful bone lytic lesions may be treated with radiation therapy. Patients receive i.v. bisphosphonates to reduce the risk of progressive bone disease and fractures (Rosen 2003; Morgan 2011).
Patients with MM (receiving HDT) perceive different symptoms (sleep and mood disturbances, diminished functional performance, pain, shortness of breath, distress, sadness and difficulty paying attention. Symptoms are interrelated and a vicious circle may be present (Coleman 2011; Anderson 2007).
Literature review: Exercise in patients with MM Only 3 RCT studies (Coleman 2003 & 2008 & 2012) and 1 single arm pilot study (Groeneveldt 2013) regarding the effect of exercise in patients with MM have been identified. Coleman investigated patients undergoing tandem autologous peripheral blood stem cell transplantation with no risk of fracture, while Groeneveldt investigated MM survivors. All the exercise programs were individualized and home-based, although one study also included weekly supervised training the first three months and monthly the following 3 months. The exercise programs, all compromising stretching, aerobic training and strength resistance training, had a duration of 6 months, and 3 of them started during induction and HDT. The controls were advised to walk 20 minutes 3 times a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Newly diagnosed with Multiple Myeloma requiring treatment.
- •The patient must be able to speak and understand Danish and be able to give his/her informed consent.
排除标准
- •Patients with spinal cord compression
- •Unstable vertebral fracture (SINS score >12) (52)
- •Untreated cardiac failure and untreated cardiac arrythmia
- •Severe chronic cardiac failure (NYHA 3-4)
- •Other severe comorbidity that will not allow physical training, e.g. neurological or uncompensated liver failure and psychological or psychiatric disorder that will not allow compliance in physical training.
结局指标
主要结局
Change in isometric knee extension strength measured by handhold dynamometer
时间窗: From baseline to follow-up after 11 weeks
kilogram and newton
次要结局
- Change in isometric knee extension strength measured by handhold dynamometer(Baseline and follow-up after 6 months and 12 months)
- Change in lower limb strength measured by Sit-to-Stand Test(Baseline and follow-up after 11 weeks, 6 months and 12 months)
- Change in grip strength measured by hand dynamometer(Baseline and follow-up after 11 weeks, 6 months and 12 months)
- Change in aerobic capacity measured by 6 Minutes Walk Test(Baseline and follow-up after 11 weeks, 6 months and 12 months)
- Change in Quality of Life assessed by self-reported questionnaire(Baseline and follow-up after 11 weeks, 6 months and 12 months)
- Change in pain assessed by self-reported questionnaire(Baseline and follow-up after 11 weeks, 6 months and 12 months)
- Change in level of physical activity measured by accelerometer(Baseline and follow-up after, 4 weeks, 7 weeks, 11 weeks, 6 months and 12 months)
- Change in bone disease - dynamic markers(Baseline and follow-up after 11 weeks, 6 months and 12 months)
- Change in bone disease - Bone Mineral Density assessed by DEXA scans(Baseline and follow-up after 6 months and 12 months)
- Change in Lean Body Mass assessed by DEXA scans(Baseline and follow-up after 11 weeks, 6 months and 12 months)