High Grade GliomaNCT03775369
Glioma and Exercising
A study testing endurance training, social support and counseling and resistance training in people with High Grade Glioma, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- endurance training, social support and counseling and resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 26 Oct 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel, Department of Neurosurgery
Basel, 4031
Department of Sport, Exercise and Health, University of Basel
Basel, 4052
About this study
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
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
Read the 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).
- Conditions
- High Grade Glioma
- Being tested
- endurance training, social support and counseling, resistance training
- Keywords
- interventions of physical activity and exercising (PAE), resistance training, endurance training
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance trainingOther
physical activity and exercising (PAE)
social support and counselingOther
social support and counseling
resistance trainingOther
physical activity and exercising (PAE)
| Study group | Role | What they receive |
|---|---|---|
| Endurance training | Active comparator | 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 Receives: Other: endurance training |
| Resistance training | Active comparator | 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 Receives: Other: resistance training |
| Control condition | Active comparator | 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 Receives: Other: social support and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: Baseline and week 3 and week 6
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline and week 3 and week 6
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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; %).
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start26 Oct 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
- Responsible party
- Sponsor
- Investigators
- Serge Brand, PD Dr. phil, Principal investigator, Department of Sport, Exercise, and Health, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775369
- Sponsor's protocol ID
- 2018-01314; ch18Cordier
- Other IDs
- 2018
- Status last verified
- May 2022
- First submitted
- 4 Dec 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31399142
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03775369
- Acronym / sponsor ID
- 2018-01314; ch18Cordier
- Conditions
- High Grade Glioma
- Keywords
- interventions of physical activity and exercising (PAE), resistance training, endurance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endurance training | Active comparator | Other: endurance trainingEndurance 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 | Active comparator | Other: resistance trainingResistance 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 | Active comparator | Other: social support and counselingControl 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endurance trainingphysical activity and exercising (PAE) | Other | Endurance training |
| social support and counselingsocial support and counseling | Other | Control condition |
| resistance trainingphysical activity and exercising (PAE) | Other | Resistance training |
Primary outcome
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
3 secondary outcomes
Change in sleep continuity assessed by EEG
Time frame: Baseline and week 6
Change in C reactive protein (CRP) (mg/l)
Time frame: Baseline and week 6
Change in sleep architecture (min; %)
Time frame: Baseline and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 31399142Cordier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge Brand, PD Dr. phil principal investigator
Department of Sport, Exercise, and Health, University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endurance training, social support and counseling and resistance training in people with High Grade Glioma, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy Scale (FACT) (time frame: Baseline and week 3 and week 6). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.