Glioma and Exercising

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

endurance training

social support and counseling

resistance training

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

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

NCT ID

NCT03775369

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

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