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Glioma and Exercising

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ClinicalTrials.gov Identifier: NCT03775369
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
High Grade Glioma Other: endurance training Other: social support and counseling Other: resistance training Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Endurance training

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
physical activity and exercising (PAE)

Active Comparator: Resistance training

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
physical activity and exercising (PAE)

Active Comparator: Control condition

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
social support and counseling




Primary Outcome Measures :
  1. Change in Functional Assessment of Cancer Therapy Scale (FACT) [ 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.

  2. Change in Hamilton Depression Rating Scale (HDRS) [ 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

  3. Change in Intolerance of Uncertainty Scale (IU) [ 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

  4. Change in Insomnia Severity Index (ISI) [ 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)

  5. Change in Perceived Stress Scale (PSS) [ 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.

  6. Change in Fatigue Severity Scale [ 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

  7. Change in Mental Toughness Questionnaire (MTQ48) [ 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

  8. Change in International Physical Activity Questionnaire [ 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.

  9. Change in submaximal 6-min walking test (6MWT) [ 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

  10. Change in Grip force [ 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


Secondary Outcome Measures :
  1. Change in sleep continuity assessed by EEG [ 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)

  2. Change in C reactive protein (CRP) (mg/l) [ 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)

  3. Change in sleep architecture (min; %) [ 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; %).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775369


Contacts
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Contact: Serge Brand, PD Dr. phil 0041 61 207 47 82 serge.brand@upkbs.ch
Contact: Dominik Cordier, PD Dr. med 0041 61 207 47 82 dominik.cordier@usb.ch

Locations
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Switzerland
University Hospital Basel, Department of Neurosurgery Recruiting
Basel, Switzerland, 4031
Contact: Dominik Cordier, PD Dr. med       dominik.cordier@usb.ch   
Department of Sport, Exercise and Health, University of Basel Recruiting
Basel, Switzerland, 4052
Contact: Serge Brand, PD Dr. phil       serge.brand@upkbs.ch   
Sub-Investigator: Markus Gerber, Prof. Dr. phil         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
Investigators
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Principal Investigator: Serge Brand, PD Dr. phil Department of Sport, Exercise and Health, University of Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03775369     History of Changes
Other Study ID Numbers: 2018-01314; ch18Cordier
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
interventions of physical activity and exercising (PAE)
resistance training
endurance training
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue