Glioma and Exercising

NCT03775369 | Completed

• 1 other identifier: 2018-01314; ch18Cordier
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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

Conditions

High Grade Glioma

Keywords

interventions of physical activity and exercising (PAE); resistance training; endurance training

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in sleep continuity assessed by EEG

  Baseline and week 6

• Change in C reactive protein (CRP) (mg/l)

  Baseline and week 6

• Change in sleep architecture (min; %)

  Baseline and week 6

Study Arms (3)

Endurance training

ACTIVE COMPARATOR

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

Resistance training

ACTIVE COMPARATOR

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

Control condition

ACTIVE COMPARATOR

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

Interventions

endurance training OTHER

physical activity and exercising (PAE)

Endurance training

social support and counseling OTHER

social support and counseling

Control condition

resistance training OTHER

physical activity and exercising (PAE)

Resistance training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health: collaborator

Study Sites (2)

University Hospital Basel, Department of Neurosurgery

Basel, 4031, Switzerland

Location

Department of Sport, Exercise and Health, University of Basel

Basel, 4052, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31399142 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

Endurance Training; Counseling; Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Serge Brand, PD Dr. phil

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 13, 2018
• Study Start: October 26, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CH (2)