Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Effect of an APA program on cognitive functions (speed function of information processing)
研究概览
简要总结
Various recent scientific data testify to the cognitive deficiencies of cancer patients, called Cancer-Related Cognitive Impairments (CRCI) (Noal, Daireaux & Joly, 2010). At the same time, regular physical activity (aerobic, muscle building, and yoga) has been shown to decrease CRCIs, although commonly used cognitive measures are self-reported (Zimmer et al., 2016). The investigators will develop an interventional study using objective measures of cognition to confirm the cause-and-effect relationship, and specify the orientation of the cognitive effects of the adapted physical activities. The main and original objective will be to determine if the cognitive functions most affected by CRCI (episodic memory, inhibition, treatment speed) can be optimized in patients undergoing treatment.
详细描述
- Inclusion procedure and saving selection failures Participation in this study will be offered to patients during their care in day hospital (= inclusion visit).
Any patient giving express consent to participation and meeting the criteria for inclusion and non-inclusion will then be included in the study.
Each patient will then be identified by his or her initials as a patient number in the study, directly on the basis of collecting the data from the study. 2. Study progress for patients Data collection takes place over two different periods. Each period lasts 12 weeks. The Adapted Physical Activity (APA) program is 8 weeks old.
The first period will run from mid-January to early April (first cohort) to collect data from the first patients in the experimental group.
The second period will be from mid-February to the end of April. During this one, it will be necessary to collect the data of the last patients of the experimental group (second cohort) The first two weeks of each period (weeks 1 and 2, weeks 4 and 5) are dedicated to recruiting patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Male or female> or = 18 years old
- •Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.
- •Any type of cancer
- •Beneficiary of a social protection scheme
- •Having as mother tongue the French language
- •Patient information and obtaining express consent
排除标准
- •Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).
- •Minor subjects
- •Pregnant women, likely to be pregnant or breastfeeding
- •Subjects with sensory disabilities affecting vision or hearing
- •Neurological or psychiatric antecedents
- •Persons deprived of liberty or guardianship (including trusteeship).
研究组 & 干预措施
Adapted Physical Activity Program
Patients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week.
干预措施: Adapted Physical Activity Program (Behavioral)
结局指标
主要结局
Effect of an APA program on cognitive functions (speed function of information processing)
时间窗: 8 weeks
For speed function of information processing, effect of APA program on cognitive functions is evaluated with XO letters comparison test. During the XO letters comparison test, the participants will have to check the maximum number of identical or different boxes according to the combination of the two letters presented (XO, OX, XX or OO) in 30 seconds.
Effect of an APA program on cognitive functions (Episodic Memory Function)
时间窗: 8 weeks
For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
Effect of an APA program on cognitive functions (inhibition)
时间窗: 8 weeks
For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
次要结局
- To determine if the APA program modifies PA (Physical Activity) patterns in daily life(8 weeks)
- Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.(8 weeks)