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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
physical activity and exercising (PAE)
social support and counseling
physical activity and exercising (PAE)
University Hospital Basel, Department of Neurosurgery
Basel, Switzerland
Department of Sport, Exercise and Health, University of Basel
Basel, Switzerland
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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: Baseline and week 3 and week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline and week 3 and week 6
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)
Time frame: 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)
Time frame: 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; %).
Time frame: Baseline and week 6