SensiEx - Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy After Treatment for Breast Cancer a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation
研究概览
简要总结
CIPN is induced by neurotoxic chemotherapeutic agents and manifests with sensory and/or motor deficits. It is associated with significant disability and poor recovery. Common symptoms include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. The purpose of the study is to compare effects of sensory vibrations training to conventional aerobic and strenght exercise on neurophatic symptoms related to chemotherapy treatment.
详细描述
Aim: To (a) compare the effects of WBV exercise compared to regular cardiovascular and resistance exercise (CAR) on the primary outcome of (a) CIPN symptoms and secondary outcomes of (b) balance, physical function, and quality of life.
Based on previous pilot study findings, we hypothesize that WBV exercise compared to CAR will reduce relevant symptoms to a larger degree, such as the loss of peripheral deep sensitivity, pain, weakened or absent reflexes and loss of balance control (aim a) and that patients will experience an improvement in physical function and quality of life (aim b).
The study employs a prospective, multicenter, two-armed, randomized controlled design. Study participants will be informed about the study procedure and sign a written informed consent. Patients will then be assigned randomly either to the WBV group or the CAR group. Patients allocated to the WBV group receive a defined WBV exercise program twice a week in addition to their usual treatment. Patients in conventional aerobic and resistance exercise (CAR) group will receive a defined exercise program twice a week in addition to their usual treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with breast cancer, aged 18-80 years,
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2,
- •completed chemotherapy in the past 3 months. Experiencing symptoms of CIPN
排除标准
- •pre-existing neuropathy of other cause (eg, diabetes),
- •given contraindications for WBV including instable bone metastases and severe cardiovascular disease.
研究组 & 干预措施
Whole Body Vibration exercise - WBV
The vibration exercises take place on a tri-planar vibration platform (Power Plate) according to the initially determined setting for each individual (highest, though feasible neuromuscular response). . Each session lasts for about 15-30 min in total, leaving sufficient time for regeneration. Training consists of at least four vibration exercises, chosen from a standardized pool of exercises with increasing difficulty in order to allow for individual, optimal progression. All sessions and adherence are documented by the exercise supervisor. Adverse events are documented, and patients asked to give feedback regarding the feasibility and subjective impression of each individual setting. All training sessions will be supervised. The participants rating of perceived exertion (RPE) will be assessed immediately after each set of exercise.
干预措施: Whole Body Vibration exercise - WBV (Other)
Conventional Aerobic and Resistance exercise - CAR
exercise sessions commence with 20 min of moderate intensity continuous aerobic exercise at a rating of perceived exertion (RPE) of 13-15 on the Borg scale. Participants complete both resistance exercises and high intensity intermittent aerobic exercises during each session. The resistance training regimen consists of 8 exercises (leg press, biceps curls, triceps extensions, bench press, shoulder press, standing row, sit ups/Russian weighted abdominal twist, and prone lying back extensions. Participants complete 2 sets of 8-12 repetitions at an initial intensity of 70 % of their estimated 1 repetition maximum (1-RM) strength and increase to 80 % of estimated 1-RM when more than 12 repetitions can be correctly performed by the participant
干预措施: Whole Body Vibration exercise - WBV (Other)
结局指标
主要结局
Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation
时间窗: Change from Baseline to 12 weeks
Monofilament testing will be performed to further quantify sensory loss at all three time points by a specially trained researcher with Von Frey Monofilament Kit using established procedures by Dyck and colleagues
Chemotherapy-induced peripheral neuropathy subjective symptoms, less symptoms
时间窗: Change from Baseline to 12 weeks
Chemotherapy-induced peripheral neuropathy assessed by The Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) symptom experience scale
次要结局
- Additional balance assessment(Change from Baseline to 12 weeks)
- Pain related to CIPN, less pain than baseline(Change from Baseline to 12 weeks)
- Performance status, improved balance and function(Change from Baseline to 12 weeks)
- Balance control, improved balance(Change from Baseline to12 weeks)
- Quality of Life assessment, improved quality of life(Change from Baseline to 12 weeks)
研究者
Yvonne Wengstrom
Professor
Karolinska Institutet