Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- To assess the feasibility of an adapted physical activity program surrounding an autograft
研究概览
简要总结
Therapeutic intensification followed by an autograft of hematopoietic stem cells is a standard of care for young patients with myeloma from the first line and for lymphoma from the second or third line of treatment. This procedure remains toxic in the short and medium term with significant mortality and morbidity: the average mortality varies from 1.4 to 5%. The causes of death are linked to a severe infection, visceral bleeding or vital organ failure. This risk of mortality is partly correlated with sarcopenia.
Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.
The positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.
The objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.
This is a feasibility study.
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
- •Age ≥ 18 years,
- •Patient with lymphoma or myeloma justifying an autograft of hematopoietic stem cells whatever the line of treatment,
- •Patient affiliated to a social security scheme,
- •Patient who has given written consent before any specific procedure related to the study
排除标准
- •Central and / or peripheral neurological deficit not allowing adapted physical activity sessions to be carried out,
- •Uncontrolled hypertension,
- •Left ventricular Ejection Fraction <50%,
- •Chronic respiratory insufficiency with alterations in the functional respiratory investigations,
- •Active viral infection: hepatitis B, C and HIV,
- •Pregnancy or breastfeeding,
- •Persons deprived of their liberty or under guardianship
- •Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial,
- •Patient who can't follow protocol for psychological, social, family or geographic reasons.
结局指标
主要结局
To assess the feasibility of an adapted physical activity program surrounding an autograft
时间窗: 6 months post-autograft
Proportion of patients performing all sessions offered per week and who performed exercises at home
次要结局
- To assess the global physical activity load by patient and by session(6 months post-autograft)
- To assess sexual function(12 months post-autograft)
- To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft(6 months post-autograft)
- To assess quality of life(12 months post-autograft)
- To assess fatigue(12 months post-autograft)
- To assess the prevalence of endocrinal disorder(28 months)
- To assess the prevalence of autograft's complication(28 months)
- To assess the response rate(28 months)
- To assess progression free survival(28 months)
- To assess the delay the period for resuming professional activity for the patients concerned, after the autograft(28 months)
- To assess patient's satisfaction(6 months post-autograft)
- To assess the duration and the cost of the hospitalization for the autograft(6 months)