Effects of Neuromuscular Electrical Stimulation Combined With Resistance Exercises on Muscle Strength in Adult Hematological Cancer Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Muscle Strength Evaluation
研究概览
简要总结
Physical activity levels of adult hematologic cancer patients are deficient. The resulting physical inactivity causes fatigue, muscle loss, and deterioration in physical performance values. However, physical exercise programs still play a minor role in treating hematological malignancies. In addition, there are no reliable data in the literature regarding risk factors, feasibility, and exercise results in individuals with hematological malignancies. Although it is known that the use of corticosteroids, which are among the drugs given during chemotherapy, causes muscle weakness, there are no physical exercise programs performed with this patient group in the literature. The current study aims to compare the effects of resistance exercise and resistance exercise combined with neuromuscular electrical stimulation on muscle strength, functional lower extremity strength, and mobility in hematological cancer patients during chemotherapy.
详细描述
Although people with hematological malignancies have to endure long stages of treatment and inactivity that are known to reduce their physical performance levels, it is still common practice to rest and avoid intense exercise. Although physical activity and exercise are important approaches to many diseases, their effects on cancer have been studied recently. There are still not enough studies in this area and it is not widely used. In recent studies, it is thought that exercise may benefit the symptoms that develop due to treatment in cancer patients. Even in the presence of severe muscle weakness and fatigue, skeletal muscle provides great adaptation when there is an appropriate exercise stimulus. In addition, exercise can increase immune functions, so it is thought that exercise practices in hematological cancer patients can specifically improve cellular functions such as microbial phagocytosis, T-cell proliferation, vaccine response, and killing tumor cells. There are various studies and approaches that try to create a different strategy and include physical exercise in the treatment strategy of hematological malignancies. These exercise programs generally include aerobics, flexibility, and resistance training methods. The necessity of developing alternative methods to exercise is emphasized in the literature due to the development of complications that affect participation in basic exercises such as walking. Resistance exercise training has been effective in improving muscle strength and endurance in cancer survivors, with most of the research on those with breast cancer, prostate cancer, and head and neck cancer. The number of studies providing strengthening training in patients with hematological cancer is limited. Neuromuscular electrical stimulation (NMES) has proven efficacy in improving muscle strength in a variety of populations. NMES training also has applicability for the cancer population to prevent treatment-related complications and improve health-related quality of life. However, there is still no high-level evidence to support the administration of NMES in cancer patients. In the present study, we aimed to evaluate the effect of resistance exercise improve muscle weakness in hematological cancer patients receiving intensive chemotherapy after HSCT. In addition, we aimed to evaluate the effect of resistance exercise and NMES training on fatigue, mobility, and quality of life in hematological cancer patients.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hematological cancer,
- •≥ 18 years old
- •ECOG Performance Status to be between 1-3
- •Hemoglobin; 8-10gr / dl and over
- •Receiving platelet support related to thrombocytopenia and/or having a platelet value of 20.000 mm3 or more
- •Leukocyte (WBC) count being 3000 μL and above
- •Giving written consent to participate in the study
排除标准
- •Comorbidities that cause fatigue (eg multiple sclerosis, Parkinson's disease, heart failure)
- •Presence of previously diagnosed heart disease
- •Using a pacemaker
- •Rapid deterioration of the general condition (sudden uncontrolled weight loss, confused consciousness, high C reactive protein (CRP) values)
- •Brain metastasis or femoral bone metastasis
- •Having dementia or psychotic condition
- •Being depressed and /or taking medication to treat depression
- •Presence of epilepsy
- •Presence of neuropathy
- •Having sensory defects in the NMES application area
- •Denying NMES application
结局指标
主要结局
Muscle Strength Evaluation
时间窗: Change from Baseline Muscle Strength through study completion, an average of 6 weeks
Participants' muscle strength measurements will be made using a digital hand dynamometer (J Tech Commander Muscle Tester). The patients will be seated in the appropriate position and the dynamometer will be placed in the dominant leg to give resistance to the muscle to be evaluated. While patients press the dynamometer as hard as possible for three seconds, the evaluator will give resistance to prevent any movement to provide an isometric contraction. Following the familiarization test, patients will perform three trials with standardized verbal encouragement and the highest strength (kilogram, kg) sustained for over half a second will be recorded.
Functional Muscle Strength Evaluation
时间窗: Change from Baseline Functional Muscle Strength through study completion, an average of 6 weeks
Lower extremity functional strength will be evaluated using the "Sit and Stand for 30 sec" test. The patient will be instructed to stand up and sit back and forth from a standardized chair as quickly as possible in 30 seconds without using his arms. Participants will be able to use their hands to help them stand as needed, and standardized verbal encouragement will be provided to continue sitting and standing throughout the test.
次要结局
- Anthropometric Assessment(Baseline and Immediately after completion of study, an average of 6 weeks)
- Mobility Assessment(Baseline and Immediately after completion of study, an average of 6 weeks)
- The Brief Fatigue Scale(Baseline and Immediately after completion of study, an average of 6 weeks)
- European Cancer Research and Treatment Organization Quality of Life Questionnaire(Baseline and Immediately after completion of study, an average of 6 weeks)
研究者
Elif Esma Safran
Lecturer
Acibadem University