The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors

NCT ID: NCT05116137

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Glioblastoma Multiforme of Brain; Brain Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

12-week circuit-based resistance exercise

Group Type: EXPERIMENTAL

Circuit-based resistance exercise (CRT)

Intervention Type: BEHAVIORAL

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.

Wait-list Control

Standard of care wait-list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Society (CCS)

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Melanie Keats

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Grandy, PhD

Role: PRINCIPAL_INVESTIGATOR

Dahousie University and Nova Scotia Health Authority

Mary MacNeil, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

References

Keats MR, Grandy SA, Blanchard C, Fowles JR, Neyedli HF, Weeks AC, MacNeil MV. The Impact of Resistance Exercise on Muscle Mass in Glioblastoma in Survivors (RESIST): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 4;11(5):e37709. doi: 10.2196/37709.

Reference Type: DERIVED

PMID: 35507403 (View on PubMed)

Other Identifiers

NSH RESIST Trial

Identifier Type: -

Identifier Source: org_study_id