Glioma and Exercising

• ClinicalTrials.gov Identifier: NCT03775369
• Recruitment Status: Completed
• First Posted: December 13, 2018
• Last Update Posted: May 18, 2022
• Sponsor: University Hospital, Basel, Switzerland
• 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

Tracking Information

• First Submitted Date: December 4, 2018
• First Posted Date: December 13, 2018
• Last Update Posted Date: May 18, 2022
• Actual Study Start Date: October 26, 2018
• Actual Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 12, 2018)

• 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.
• 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
• 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
• 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)
• 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.
• 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
• 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
• 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.
• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 12, 2018)

• 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)
• 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)
• 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; %).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: High Grade Glioma

Intervention

• Other: endurance training
  physical activity and exercising (PAE)
• Other: social support and counseling
  social support and counseling
• Other: resistance training
  physical activity and exercising (PAE)

Study Arms

• 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

  Intervention: Other: endurance training
• 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

  Intervention: Other: resistance training
• 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

  Intervention: Other: social support and counseling

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 17, 2022): 39
• Original Estimated Enrollment (submitted: December 12, 2018): 45
• Actual Study Completion Date: February 28, 2022
• Actual Primary Completion Date: February 28, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT03775369
• Other Study ID Numbers: 2018-01314; ch18Cordier
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Basel, Switzerland
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current
• Collaborators: University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health

Investigators

• Principal Investigator: Serge Brand, PD Dr. phil; Department of Sport, Exercise, and Health, University of Basel

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: May 2022