The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors

Brain Cancer Clinical Trial

— RESIST  

Official title:

The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors (RESIST)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05116137
• Other study ID #: NSH RESIST Trial
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Glioblastoma patients are confronted with a debilitating disease associated with a low survival rate and poor quality of life. The goal of this study will be to reach a largely underrepresented population in the exercise literature and explore the role of a tailored circuit-based resistance training program on functional fitness (i.e., ability to carry out tasks of daily living) and associated health outcomes (e.g., quality of life) for GBM patients on active treatment.

Description:

PROBLEM: Glioblastoma multiforme (GBM) is the most common brain malignancy accounting for approximately 48% of all brain tumors. GBMs are highly vascular and can cause vasogenic brain edema and mass effect, which can worsen the neurologic symptoms associated with the disease. Corticosteroids (i.e., Dexamethasone; DEX) are the treatment of choice to reduce vasogenic edema and intercranial pressure associated with GBM. However, the use of steroids comes at a cost. High dose steroid therapy and/or long-term use results in muscle myopathy (i.e., muscle weakness) in 10-60% of GBM patients, significantly reducing functional ability as well as quality of life (QOL). Thus, adjuvant therapies are needed to help patients maintain their functional ability and QOL. There is a wealth of evidence to support the use of exercise as an adjuvant therapy to improve functional ability as well as help manage treatment-related symptoms. Resistance training (RT) has been shown to increase muscle mass, strength, and functional ability in aging adults and several cancer populations. While limited, studies in GBM have shown that exercise is safe and feasible for this population and that it can improve functional performance. However, no specific research has been performed to determine whether RT can be successfully used in GBM to prevent or reduce steroid induced muscle myopathy. Therefore, the primary purpose of this study is to establish whether an individualized circuit-based RT program will improve functional fitness for patients on active treatment and receiving steroids.

METHODS: This is a two-armed randomized control trial with repeated measures. Thirty-eight adult (18+ years) patients diagnosed with either primary or secondary GBM who are scheduled to receive standard radiation and concurrent adjuvant Temozolomide chemotherapy post-surgical debulking as well as received any dose of DEX will be recruited through the neuro-oncology clinic and the QEII Cancer Center. Patients will be randomly allocated to a standard of care group (SOC) or SOC+RT group (EX). Those in the SOC group will be advised to maintain an active lifestyle for the 12-week intervention whereas those in the EX group will receive a personalized 12-week circuit-based RT program. This program will consist of 3-4 supervised RT sessions/wk. During each session participants will perform a RT program that is comprised of 3 circuits. Each circuit will include 3 sets of 3 different exercises. Each exercise set will be 1 minute in duration (20 seconds/exercise) with 1 minute of rest between sets. Initial exercise intensity will be light and will increase throughout the program based on the participant's progress. All exercise programs will be designed and supervised by a Clinical Exercise Physiologist (CEP). The primary outcome measure for the study is functional performance which will be assessed using the Short Physical Performance Battery and hand grip strength. Secondary outcome measures will include body composition, aerobic fitness, physical activity levels, general health, QOL, fatigue, and cognitive function. All measures will be assessed pre/post-intervention. Safety and exercise adherence will be assessed throughout the study.

ANALYSIS: Descriptive statistics will be used to describe the population, accrual, program adherence and safety. Outcome data will be analyzed using an intention to treat approach. All participants will be entered into a mixed effects model with participant group assignment (EX, SOC) at randomization and timepoint (pre- and post-test) as fixed factors and participant entered as a random factor. Due to feasibility in recruiting participants in the allotted time, the study will not be fully powered to detect sex-based differences; however, effect sizes associated with the intervention will be calculated and presented separately for each sex.

SIGNIFICANCE: This study will demonstrate the not only is RT safe and feasible for those with GBM, but that it also significantly improves functional status by protecting against myopathy. This will help GBM patients maintain their independence which could lead to marked improvements in QOL.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically confirmed diagnosis of either primary or secondary GBM

• received any dose of DEX

• Karnofsky Performance Status (KPS) >70

• English fluency

• physician approval

• willingness to travel to Halifax to participate.

Exclusion Criteria:

• unstable or symptomatic cardiac or pulmonary disease, injury or co-morbid disease that precludes ability to safely exercise

• significant cognitive limitations

• uncontrolled seizures associated with impaired awareness

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Glioblastoma
• Glioblastoma Multiforme of Brain

Intervention

Behavioral:
• Circuit-based resistance exercise (CRT)
CRT is a common training method used to foster aerobic fitness, muscular endurance and strength, as well as neuromuscular adaptations in one workout. CRT is comprised of several sets of different exercises with little rest in between each set.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Canadian Cancer Society (CCS)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Study Feasibility - Participant Accrual	Participant accrual calculated as % of patients referred divided by number of patients consented to participation	Captured over the 12-week study period
Other	Study Feasibility - Participant Attrition	Participant attrition calculated as % of patients who complete 12-week study divided by number who withdraw from study	Captured over the 12-week study period
Other	Study Feasibility - Participant Adherence	Participant program adherence calculated as % of exercise sessions completed divided by total number of available exercise sessions over 12-week intervention	Captured over the 12-week study period
Other	Study safety	Adverse events will be recorded	Captured over the 12-week study period
Primary	Functional Performance	Short Physical Performance Battery to assess activities of daily living	Baseline to post-intervention (12-week) change
Primary	Grip strength	Measured by handheld dynamometer	Baseline to post-intervention (12-week) change
Secondary	Body Mass Index (BMI)	Weight (kg) and height (m) will be used to calculate BMI	Baseline to post-intervention (12-week) change
Secondary	Body composition and Muscle Mass	Arm, waist, and calf circumference (cm)	Baseline to post-intervention (12-week) change
Secondary	Muscle Mass	Muscle mass and quality - 3T diagnostic magnetic resonance imaging	Baseline to post-intervention (12-week) change
Secondary	Aerobic fitness	6 minute walk will be used to calculate aerobic fitness	Baseline to post-intervention (12-week) change
Secondary	Physical activity	Godin Leisure Time Physical Activity Questionnaire - Leisure Score Index will be used to calculate self-reported leisure physical activity	Baseline to post-intervention (12-week) change
Secondary	Physical, functional, emotional, and social/family quality of Life	Functional Assessment of Cancer Therapy - Brain (FACT-Br) - 50 item scale; total scale score range 0-200; higher scores indicate higher overall QOL	Baseline to post-intervention (12-week) change
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) - 13 item scale; score range 0-52; higher scores indicate less fatigue	Baseline to post-intervention (12-week) change
Secondary	Cognitive functioning 1	Trail making test-b; Time taken to complete each task and number of errors made during each task are recorded and compared with normative data. Time to complete the task is recorded in seconds; the greater the number of seconds to complete the task, the greater the impairment.	Baseline to post-intervention (12-week) change
Secondary	Cognitive functioning 2	Hopkins Verbal Learning Test-Revised for memory; total recall and recognition scores will be calculated	Baseline to post-intervention (12-week) change
Secondary	General Health (EuroQol) 5 Dimension - 5 Level	Mobility, self-care, usual activities, pain/discomfort, anxiety/depression (EuroQol-5Dimension-5Level; EQ-5D-5L) - 5 dimensions; higher scores indicate higher problems	Baseline to post-intervention (12-week) change
Secondary	General Health (EuroQol) Visual Analog Scale	EuroQol Visual Analog Scale 0-100; lower scores indicate worse health	Baseline to post-intervention (12-week) change