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Completed

NCT Number: NCT03775369

Glioma and Exercising

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endurance training

Other

physical activity and exercising (PAE)

social support and counseling

Other

social support and counseling

Resistance training

Other

physical activity and exercising (PAE)

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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.

  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

  7. 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

  8. 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.

  9. 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

  10. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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; %).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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