Clinical trial NCT03775369: Glioma and Exercising
Official title: Influence of Physical Activity in Patients With High Grade Glioma (WHO III° and IV°) on Patients' Psychological Well Being, Sleep and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Grade Glioma
Keywords: interventions of physical activity and exercising (PAE)
resistance training
endurance training
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
First posted: 2018-12-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy Scale (FACT)
timeFrame: Baseline and week 3 and week 6
measure: Change in Hamilton Depression Rating Scale (HDRS)
timeFrame: Baseline and week 3 and week 6
measure: Change in Intolerance of Uncertainty Scale (IU)
timeFrame: Baseline and week 3 and week 6
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline and week 3 and week 6
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline and week 3 and week 6
measure: Change in Fatigue Severity Scale
timeFrame: Baseline and week 3 and week 6
measure: Change in Mental Toughness Questionnaire (MTQ48)
timeFrame: Baseline and week 3 and week 6
measure: Change in International Physical Activity Questionnaire
timeFrame: Baseline and week 3 and week 6
measure: Change in submaximal 6-min walking test (6MWT)
timeFrame: Baseline and week 3 and week 6
measure: Change in Grip force
timeFrame: Baseline and week 3 and week 6
Secondary outcomes:
measure: Change in sleep continuity assessed by EEG
timeFrame: Baseline and week 6
measure: Change in C reactive protein (CRP) (mg/l)
timeFrame: Baseline and week 6
measure: Change in sleep architecture (min; %)
timeFrame: Baseline and week 6
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Neurosurgery
city: Basel
country: Switzerland
facility: Department of Sport, Exercise and Health, University of Basel
Study officials:
affiliation: Department of Sport, Exercise, and Health, University of Basel
name: Serge Brand, PD Dr. phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordier D, Gerber M, Brand S. Effects of two types of exercise training on psychological well-being, sleep, quality of life and physical fitness in patients with high-grade glioma (WHO III and IV): study protocol for a randomized controlled trial. Cancer Commun (Lond). 2019 Aug 9;39(1):46. doi: 10.1186/s40880-019-0390-8.