Glioma and Exercising

May 17, 2022 updated by: University Hospital, Basel, Switzerland

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4052
        • Department of Sport, Exercise and Health, University of Basel
      • Basel, Switzerland, 4031
        • University Hospital Basel, Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 3 and week 6
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
Baseline and week 3 and week 6
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
Baseline and week 3 and week 6
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)
Baseline and week 3 and week 6
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.
Baseline and week 3 and week 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
Baseline and week 3 and week 6
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
Baseline and week 3 and week 6
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.
Baseline and week 3 and week 6
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
Baseline and week 3 and week 6
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
Baseline and week 3 and week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and week 6
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)
Baseline and week 6
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; %).
Baseline and week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 26, 2018

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

February 28, 2022

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (ACTUAL)

December 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01314; ch18Cordier

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High Grade Glioma

Clinical Trials on endurance training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe