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Glioma and Exercising

Primary Purpose

High Grade Glioma

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
endurance training
social support and counseling
resistance training
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for High Grade Glioma focused on measuring interventions of physical activity and exercising (PAE), resistance training, endurance training

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Basel, Department of Neurosurgery
  • Department of Sport, Exercise and Health, University of Basel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Endurance training

Resistance training

Control condition

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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
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
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)
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.
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
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
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.
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
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

Secondary Outcome Measures

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)
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)
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; %).

Full Information

First Posted
December 4, 2018
Last Updated
May 17, 2022
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
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1. Study Identification

Unique Protocol Identification Number
NCT03775369
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Glioma
Keywords
interventions of physical activity and exercising (PAE), resistance training, endurance training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endurance training
Arm Type
Active Comparator
Arm Description
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
Arm Title
Resistance training
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
endurance training
Intervention Description
physical activity and exercising (PAE)
Intervention Type
Other
Intervention Name(s)
social support and counseling
Intervention Description
social support and counseling
Intervention Type
Other
Intervention Name(s)
resistance training
Intervention Description
physical activity and exercising (PAE)
Primary Outcome Measure Information:
Title
Change in Functional Assessment of Cancer Therapy Scale (FACT)
Description
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
Title
Change in Hamilton Depression Rating Scale (HDRS)
Description
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
Title
Change in Intolerance of Uncertainty Scale (IU)
Description
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
Title
Change in Insomnia Severity Index (ISI)
Description
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
Title
Change in Perceived Stress Scale (PSS)
Description
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
Title
Change in Fatigue Severity Scale
Description
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
Title
Change in Mental Toughness Questionnaire (MTQ48)
Description
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
Title
Change in International Physical Activity Questionnaire
Description
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
Title
Change in submaximal 6-min walking test (6MWT)
Description
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
Title
Change in Grip force
Description
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
Secondary Outcome Measure Information:
Title
Change in sleep continuity assessed by EEG
Description
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
Title
Change in C reactive protein (CRP) (mg/l)
Description
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
Title
Change in sleep architecture (min; %)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Brand, PD Dr. phil
Organizational Affiliation
Department of Sport, Exercise and Health, University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Department of Neurosurgery
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Department of Sport, Exercise and Health, University of Basel
City
Basel
ZIP/Postal Code
4052
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31399142
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.
Results Reference
derived

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Glioma and Exercising

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