Endurance training
Otherphysical activity and exercising (PAE)
NCT Number: NCT03775369
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
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
physical activity and exercising (PAE)
social support and counseling
physical activity and exercising (PAE)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline and week 6
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
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
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; %).
University Hospital, Basel, Switzerland
Other
Influence of Physical Activity in Patients With High Grade Glioma (WHO III° and IV°) on Patients' Psychological Well Being, Sleep and Quality of Life
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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