Glioma and Exercising

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Influence of Physical Activity in Patients With High Grade Glioma (WHO III° and IV°) on Patients' Psychological Well Being, Sleep and Quality of Life

Conditions
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High Grade Glioma

Intervention / Treatment
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* Other: endurance training
* Other: social support and counseling
* Other: resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endurance training<br>Endurance Training (warm-up; endurance on bike; brisk walking; cooling down; group sessions; supervised; moderate and individualized exercising load): 6 weeks, 2 sessions/week, 40-60min/session | Other: endurance training<br>* physical activity and exercising (PAE)<br>|
| Active Comparator: Resistance training<br>Resistance Training (warm-up; resistance training units; cooling down; group sessions; supervised; moderate and individualized exercising load): 6 weeks, 2 sessions/week, 40-60min/session | Other: resistance training<br>* physical activity and exercising (PAE)<br>|
| Active Comparator: Control condition<br>Control condition (individualized counselling, but not intended as a bona fide intervention, that is to say: not intended to actively improve participants' well-being): 6 weeks, social support and counseling,1-2 sessions/week; 30 min/session | Other: social support and counseling<br>* social support and counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Assessment of Cancer Therapy Scale (FACT) | 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. | Baseline and week 3 and week 6 | 
| Change in Hamilton Depression Rating Scale (HDRS) | 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 | Baseline and week 3 and week 6 | 
| Change in Intolerance of Uncertainty Scale (IU) | 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 | Baseline and week 3 and week 6 | 
| Change in Insomnia Severity Index (ISI) | ISI is a 7-item screening measure for insomnia. Items answered on 5-point rating scales (0 = not at all, 4 = very much) | Baseline and week 3 and week 6 | 
| Change in Perceived Stress Scale (PSS) | 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. | Baseline and week 3 and week 6 | 
| Change in Fatigue Severity Scale | 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 | Baseline and week 3 and week 6 | 
| Change in Mental Toughness Questionnaire (MTQ48) | 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 | Baseline and week 3 and week 6 | 
| Change in International Physical Activity Questionnaire | questionnaire consists of several items and asks about the amount of days with walking, moderate and vigorous physical activity. | Baseline and week 3 and week 6 | 
| Change in submaximal 6-min walking test (6MWT) | To assess functional exercise capacity, distance walked during 6 min will be assessed and compared to reference age and gender norms | Baseline and week 3 and week 6 | 
| Change in Grip force | 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 | Baseline and week 3 and week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep continuity assessed by EEG | Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep continuity (awakenings after sleep onset: number of duration of awakenings) | Baseline and week 6 | 
| Change in C reactive protein (CRP) (mg/l) | blood samples are taken before and after the 6MWT and grip force test to assess inflammatory marker CRP (mg/l) | Baseline and week 6 | 
| Change in sleep architecture (min; %) | Sleep is objectively assessed via an easy-to-use in-home sleep-EEG. It consists of three electrodes and measures sleep architecture (wake, Non-rapid eye movement (REM)- sleep stages 1-4 (min; %); REM-sleep (min; %). | Baseline and week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interventions of physical activity and exercising (PAE), resistance training, endurance training