Influence of Physical Activity in Patients With High Grade Glioma (WHO III° and IV°) on Patients' Psychological Well Being, Sleep and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Change in Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
To investigate the influence of two physical activity and exercising (PAE) interventions, namely resistance training and endurance training in relation to quality of life, depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions), along with cancer-related dimensions
详细描述
Patients with high grade glioma (WHO III° and IV°) and undergoing radiotherapy, chemotherapy, or both radio- and chemotherapy suffer from decreased quality of life (QoL). This study is to analyse the influence of two adjuvant interventions of physical activity and exercising (PAE) (namely resistance training and endurance training) in relation to quality of life, depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with high grade glioma (WHO III° and IV°), and undergoing radiotherapy, chemotherapy, or both
- •Willing and able to follow the study intervention
- •Signed written informed consent
排除标准
- •Severe psychiatric (psychosis, suicidal behavior, substance use disorder) and somatic comorbidities (severe cardiovascular disease, severe diabetes, impairments of the musculo-skeletal system)
- •patients not willing or able anymore to follow the study protocol.
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HDRS)
时间窗: Baseline and week 3 and week 6
HDRS scale to assess patients' severity of Depression (mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms); each item on the questionnaire is scored on a 3 or 5 point scale; a score of 0-7 is considered to be normal
Change in Perceived Stress Scale (PSS)
时间窗: Baseline and week 3 and week 6
General perceived stress is assessed with the 10-item Perceived Stress Scale (PSS). The PSS measures the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Answers were given on a five-point Likert-type scale anchored at 1 (never) to 5 (very often). Four items were reverse scored. The mean was calculated in order to obtain an overall score.
Change in Functional Assessment of Cancer Therapy Scale (FACT)
时间窗: Baseline and week 3 and week 6
Cancer-related Quality of Life (QOL) assessed by Functional Assessment of Cancer Therapy Scale (FACT), a self-report instrument which measures multidimensional QOL. The FACT evaluation system uses a 29-49 item compilation of a generic core and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments.
Change in Intolerance of Uncertainty Scale (IU)
时间窗: Baseline and week 3 and week 6
IU: 5-point rating scale (1 = not at all characteristic of me, 5 = entirely characteristic of me) indicating how much patient agrees with the item. The higher the overall score is, the more the respondent is assumed to be more intolerant of uncertainty
Change in Mental Toughness Questionnaire (MTQ48)
时间窗: Baseline and week 3 and week 6
The 48 item MTQ48 measures the subcomponents challenge, commitment, emotional and life control, and interpersonal confidence and confidence in ability. Answers are given on five-point Likert-type scales ranging from 1 (=strongly disagree) to 5 (=strongly agree), with higher scores reflecting greater MT
Change in International Physical Activity Questionnaire
时间窗: Baseline and week 3 and week 6
questionnaire consists of several items and asks about the amount of days with walking, moderate and vigorous physical activity.
Change in Insomnia Severity Index (ISI)
时间窗: Baseline and week 3 and week 6
ISI is a 7-item screening measure for insomnia. Items answered on 5-point rating scales (0 = not at all, 4 = very much)
Change in Fatigue Severity Scale
时间窗: Baseline and week 3 and week 6
nine items, and answers are given on seven-point rating scales ranging from 1 (not at all) to 7 (definitively/almost always), with higher mean scores reflecting greater fatigue
Change in submaximal 6-min walking test (6MWT)
时间窗: Baseline and week 3 and week 6
To assess functional exercise capacity, distance walked during 6 min will be assessed and compared to reference age and gender norms
Change in Grip force
时间窗: Baseline and week 3 and week 6
Maximum isometric grip force of the dominant hand is assessed using the hand dynamometer. Participants make three attempts. Mean outcomes is compared to reference data
次要结局
- Change in sleep architecture (min; %)(Baseline and week 6)
- Change in C reactive protein (CRP) (mg/l)(Baseline and week 6)
- Change in sleep continuity assessed by EEG(Baseline and week 6)