Tailored Exercise Interventions to Reduce Fatigue in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
研究概览
简要总结
Cancer-related fatigue (CRF) is a common and distressing symptom of cancer and/or cancer treatment that can persist for months or years in cancer survivors. Exercise is beneficial for the management of CRF, and general exercise guidelines for cancer survivors are available. However, exercise interventions have not been tailored to alleviate CRF in fatigued cancer survivors, and thus the potential to alleviate CRF may not have been realized. The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.
详细描述
Background and Rationale
Approximately one-third of cancer survivors experience severe and persistent fatigue for a number of years post-treatment, but this distressing symptom is often under-treated by healthcare professionals due to a lack of mechanism-targeted interventions. The assessment of cancer-related fatigue (CRF) is reliant on subjective fatigue measurements such as self-report questionnaires. Less attention has been given to objective physiological measurements. However, there are well-established techniques which allow the assessment of neuromuscular fatigue and its peripheral and central origins which could be utilized in the study of CRF. Very few studies have considered these objective measures alongside self-report scales in the study of CRF and only two have used such techniques in cancer survivors. To date, no studies have investigated neuromuscular fatigue in whole body, dynamic activity as relevant to daily tasks (and involving the lower limb due to its functional relevance to locomotion). Novel testing developed in our laboratory could be used as part of a wider screening to develop individualized interventions to alleviate CRF. It is well accepted in the field that CRF is multidimensional and in addition to a potential neuromuscular component, the role of sleep disturbance may also be implicated. Interventions targeted at improving sleep quality are therefore warranted, and there is sound evidence for the efficacy of exercise interventions in particular for improving CRF in cancer survivors. As a non-pharmacological intervention, physical activity has the strongest evidence base for treating CRF. However, the mechanisms explaining the reduction of CRF with exercise are not understood. Due to the complex and multi-factorial nature of CRF, it would be of benefit to tailor exercise interventions to the specific deficits (in regards to neuromuscular mechanisms) or difficulties (for example sleep disturbance) experienced by the individual. Ultimately, mechanism-targeted exercise interventions could be translated to clinical rehabilitation programs and lead to an improved quality of for cancer survivors.
Research Question & Objectives
The primary aim of this research is to investigate the effect of a traditional vs. tailored 12-week exercise intervention on self-reported CRF severity.
Methods
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years;
- •Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score ≤ 34;
- •Completion of treatment in ≥ 3 months and ≤ 5 years preceding enrollment;
- •Approval received from personal physician and/or a Canadian Society for Exercise Physiology-Clinical Exercise Physiologist (CSEP-CEP);
- •Command of the English language.
排除标准
- •Contraindication to experimental procedures including transcranial magnetic stimulation (TMS);
- •Diagnosed as having obstructive sleep apnea or anemia;
- •Currently participating in a structured exercise intervention;
- •Participant is pregnant.
结局指标
主要结局
Assessment of change in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
时间窗: Baseline to after the 12-week intervention, at 6 month and 12 month follow up.
Self-report questionnaire for the assessment of cancer-related fatigue.
次要结局
- Maximal Isometric Force in the Knee Extensors(Baseline and after the 12-week intervention.)
- Potentiated Doublet Twitch Force(Baseline and after the 12-week intervention.)
- Actual Wake Time(Baseline and after the 12-week intervention.)
- Voluntary Activation(Baseline and after the 12-week intervention.)
- Assessment of change in The Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline and after the 12-week intervention.)
- Assessment of change in Edmonton Symptom Assessment System-revised tiredness scale(Baseline and after the 12-week intervention, and during follow up (6 and 12 months).)
- Muscle Compound Action Potential (M-Wave) Peak-to Peak Amplitude(Baseline and after the 12-week intervention.)
- Muscle Compound Action Potential (M-Wave) Peak-to Peak Duration(Baseline and after the 12-week intervention.)
- Motor Evoked Potential (MEP) Area(Baseline and after the 12-week intervention.)
- Amplitude of the Sleep-Wake Cycle(Baseline and after the 12-week intervention.)
- Peak Time of the sleep-wake Cycle(Baseline and after the 12-week intervention.)
- Activity Index(Baseline and after the 12-week intervention.)
- Cortical Voluntary Activation(Baseline and after the 12-week intervention.)
- Motor Evoked Potential (MEP) Peak-to Peak Amplitude(Baseline and after the 12-week intervention.)
- intra-daily variability(Baseline and after the 12-week intervention.)
- Sleep Onset Latency(Baseline and after the 12-week intervention.)
- Fragmentation index(Baseline and after the 12-week intervention.)
- Assessment of change in The Social Prevision Scale (SPS)(Baseline and after the 12-week intervention.)
- Heart Rate Variability(Baseline and after the 12-week intervention.)
- Muscle Compound Action Potential (M-Wave) Area(Baseline and after the 12-week intervention.)
- Cortical Silent Period(Baseline and after the 12-week intervention.)
- inter-daily stability(Baseline and after the 12-week intervention.)
- Wake actigraphy(Baseline and after the 12-week intervention.)
- Time in bed(Baseline and after the 12-week intervention.)
- Sleep Efficiency(Baseline and after the 12-week intervention.)
- Assessment of change in The Insomnia Severity Index (ISI)(Baseline and after the 12-week intervention.)
- Assessment of change in Fat Mass(Baseline and after the 12-week intervention.)
- Assessment of change in Fat Free Mass(Baseline and after the 12-week intervention.)
- Assessment of change in Muscle Cross-Sectional Area(Baseline and after the 12-week intervention.)
- Motor Evoked Potential (MEP) Peak-to Peak Duration(Baseline and after the 12-week intervention.)
- Voluntary Electromyography (EMG)(Baseline and after the 12-week intervention.)
- Mesor of the Sleep-Wake Cycle(Baseline and after the 12-week intervention.)
- L5(Baseline and after the 12-week intervention.)
- L5 mid(Baseline and after the 12-week intervention.)
- Sleep Activity(Baseline and after the 12-week intervention.)
- Actual Sleep Time(Baseline and after the 12-week intervention.)
- Assessment of change in The Functional Assessment of Cancer Therapy (FACT) Cancer Specific(Baseline and after the 12-week intervention.)
- Assessment of change in The Modified-Godin Leisure Time Exercise Questionnaire (GLTEQ)(Baseline, after the 12-week intervention, and during follow up (6 and 12 months).)
- Assessment of change in The Brief Pain Inventory Short Form (BPI-sf)(Baseline and after the 12-week intervention.)
- Assessment of change in Bone Mineral Density(Baseline and after the 12-week intervention.)
- Blood Biomarkers(Baseline and after the 12-week intervention.)
- Assessment of change in the Centre for Epidemiological Studies Depression Scale (CES-D) questionnaire.(Baseline and after the 12-week intervention.)
- Assessment of change in Maximal Oxygen Uptake(Baseline and after the 12-week intervention.)
研究者
Guillaume Millet
Professor
University of Calgary