Glioma and Exercising

NCT ID: NCT03775369

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-26

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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High Grade Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

endurance training

Intervention Type OTHER

physical activity and exercising (PAE)

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

Group Type ACTIVE_COMPARATOR

resistance training

Intervention Type OTHER

physical activity and exercising (PAE)

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

Group Type ACTIVE_COMPARATOR

social support and counseling

Intervention Type OTHER

social support and counseling

Interventions

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endurance training

physical activity and exercising (PAE)

Intervention Type OTHER

social support and counseling

social support and counseling

Intervention Type OTHER

resistance training

physical activity and exercising (PAE)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serge Brand, PD Dr. phil

Role: PRINCIPAL_INVESTIGATOR

Department of Sport, Exercise, and Health, University of Basel

Locations

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University Hospital Basel, Department of Neurosurgery

Basel, , Switzerland

Site Status

Department of Sport, Exercise and Health, University of Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 31399142 (View on PubMed)

Other Identifiers

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2018-01314; ch18Cordier

Identifier Type: -

Identifier Source: org_study_id

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