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

Abstract

Background There is existing evidence on whether and to what degree regular exercise training improves the quality of life (QoL) among cancer survivors. However, in regards to patients with high-grade glioma (HGG; WHO grade III and IV), no conclusive study has been performed so far. The present trial aims to fill this gap by examining whether psychological well-being, sleep, QoL and physical fitness might be improved with two different types of exercise, as compared to an active control condition. Active control condition represent individuals participating at regular meetings to talk about their current life situation, though, the meetings were not intended as that of the psychotherapy group. Regular meetings are of the same frequency, duration, and intensity as the exercise interventions. Methods A total of 45 patients with HGG after undergoing neurosurgery and adjuvant radiotherapy, chemotherapy, or chemoradiotherapy will be consecutively and randomly assigned to (a) an endurance training, (b) a resistance training or (c) to an active control condition. The intervention will last for 6 consecutive weeks, consisting of 2 weekly sessions (30–45 min per session). Measurements would take place at three time points, namely at the beginning of the study (baseline), 3 weeks after the beginning of the study, and 6 weeks after the beginning of the study. The last measurement also represents the end of the study. Aerobic exercise performance will be assessed objectively with a 6-min walking test, and a handgrip test will be used to assess the upper body strength. Further, participants will complete a battery of questionnaires covering sociodemographic information, QoL, sleep quality and sleep patterns, coping with stress, state- and trait-anxiety, depression, and fatigue. In parallel, experts will use the Hamilton Depression Rating Scale to determine and rate participants’ symptoms of depression. Significance The present study will be the first to investigate and compare the impact of two different exercise modalities, namely endurance and resistance training, on physical fitness and dimensions of well-being, and sleep among patients with HGG who underwent neurosurgery followed by adjuvant radiotherapy, chemotherapy, or chemoradiotherapy. Importantly, unlike the majority of previous studies, the control condition consists of an active set-up to detect possible factual beneficial effects of exercise training, irrespective of social interactions. Trial registration https://register.clinicaltrials.gov ; identifier: NCT03775369

Acceptance and Commitment Therapy (ACT) Improves Sleep Quality, Experiential Avoidance, and Emotion Regulation in Individuals with Insomnia—Results from a Randomized Interventional Study

“…As described extensively elsewhere [ 75 , 76 , 77 , 78 , 79 , 80 ], participants in the control condition met in groups with a staff member and social worker once a week for eight consecutive weeks for about 60–70 min. They had group discussions on daily activities and daily problems.…”

“…They had group discussions on daily activities and daily problems. The control condition could not be considered as a bona fide intervention [ 75 , 76 , 77 , 78 , 79 , 80 ], given that the sessions with the staff member and social worker excluded treatment elements that were truly intended to be therapeutic [ 81 ]. Participants were just encouraged to exchange daily life experiences.…”

Health Benefit Manifestation of Improved Sleep, Physical Exercise and Selective Diets

“…In a projected study of 45 patients presenting high-grade glioma, after receiving neurosurgery and adjuvant radiotherapy, chemotherapy, or chemoradiotherapy, each was assigned randomly to (i) an endurance training, (ii) a resistance training or (iii) to an active control condition [31], over six consecutive weeks, that consisted of two-weekly sessions, comprising 30-45 min per session, and with measurements taken at three time-points, pertaining to the beginning of the study, which was baseline measure, at three weeks after the beginning of the baseline, and six weeks following the beginning of the baseline measure. Gliomas are typically malignant primary brain tumors and generally incurable demanding conditions whereby palliation and the maintenance or improvements of the patient's quality-of-life, assessed by using self-reported, validated questionnaires, represent areas of major importance.…”

Genetic variants in m6A modification core genes are associated with glioma risk in Chinese children

“…Many environmental factors have been explored, yet only one definite factor (ionizing radiation) is recognized as a causative agent. 8 , 9 , 10 Hereditary factors, lifestyle, and diet are suggested to confer risk of glioma, but causal relationships should be solidified. 11 Evidence for a genetic component to glioma risk has been growing.…”