Glioma and Exercising

High Grade Glioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775369
• Other study ID #: 2018-01314; ch18Cordier
• Status: Completed
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions), along with cancer-related dimensions

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Intervention

Other:
• endurance training
physical activity and exercising (PAE)
• social support and counseling
social support and counseling
• resistance training
physical activity and exercising (PAE)

Locations

Country	Name	City	State
Switzerland	Department of Sport, Exercise and Health, University of Basel	Basel
Switzerland	University Hospital Basel, Department of Neurosurgery	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and week 3 and week 6
Primary	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	Baseline and week 3 and week 6
Primary	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	Baseline and week 3 and week 6
Primary	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)	Baseline and week 3 and week 6
Primary	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.	Baseline and week 3 and week 6
Primary	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	Baseline and week 3 and week 6
Primary	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	Baseline and week 3 and week 6
Primary	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.	Baseline and week 3 and week 6
Primary	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	Baseline and week 3 and week 6
Primary	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	Baseline and week 3 and week 6
Secondary	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)	Baseline and week 6
Secondary	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)	Baseline and week 6
Secondary	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; %).	Baseline and week 6