The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- VO2peak
研究概览
简要总结
This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.
详细描述
In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.
The primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lymphoma participants:
- •Listed in relevant registers
- •Confirmed lymphoma diagnosis (i.e., Hodgkin lymphoma and aggressive non-Hodgkin lymphoma)
- •Completed treatment in the past two to five years without relapse or second cancer
- •Previous anthracycline treatment with or without mediastinal radiation
- •No severe cancer-related fatigue (per self-report)
- •Inclusion Criteria Lymphoma participants and non-cancer reference group:
- •Currently not performing >75 minutes/week of aerobic exercise
- •Willing and able to adhere to all study procedures.
排除标准
- •Lymphoma participants:
- •Relapse since diagnosis
- •A history, or current presence, of another diagnosis of invasive cancer of any kind
- •Exclusion Criteria Lymphoma participants and non-cancer reference group:
- •Presence of any uncontrolled- or recent cardiovascular disease
- •Has undergone heart surgery
- •Uses a pacemaker
- •Pregnancy
- •Unable to read and understand Swedish (applicable for the Swedish site only)
- •Unable to read and understand Norwegian (applicable for the Norwegian site)
- •Any physical or mental health condition restricting adherence to study protocol
研究组 & 干预措施
Aerobic Exercise
Aerobic Exercise twice weekly for 5 months.
干预措施: Aerobic Exercise (Behavioral)
Combined Aerobic and Resistance Exercise
Combined Aerobic and Resistance Exercise twice weekly for 5 months.
干预措施: Combined Aerobic and Resistance Exercise (Behavioral)
Standard Care
Standard Care, i.e no exercise intervention.
Reference Aerobic Exercise
Aerobic Exercise twice weekly for 5 months.
干预措施: Aerobic Exercise (Behavioral)
结局指标
主要结局
VO2peak
时间窗: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test
次要结局
- Systolic- and diastolic heart chamber dimensions(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Lean body mass(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Systolic- and diastolic longitudinal strain(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Maximal voluntary ventilation(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Muscle fiber area(Baseline, five months from baseline (i.e. end of intervention))
- Forced Vital Capacity(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Muscle fiber type(Baseline, five months from baseline (i.e. end of intervention))
- Forced Expiratory Volume 1 sec(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Blood volume(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Fat mass(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Diffusion capacity(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Global Health related Quality of life(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Physical activity(Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Muscle mitochondria mass(Baseline, five months from baseline (i.e. end of intervention))
- Physical activity(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
研究者
Tormod Skogstad Nilsen
Principal Investigator, PhD
Norwegian School of Sport Sciences