NCT05116137

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Mar 2022Dec 2027

First Submitted

Initial submission to the registry

October 19, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

5.8 years

First QC Date

October 19, 2021

Last Update Submit

May 28, 2026

Conditions

Glioblastoma Multiforme of BrainBrain Cancer

Keywords

ExerciseCircuit-based resistance trainingInterventionMyopathyFunctional statusQuality of lifeRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Functional Performance

    Short Physical Performance Battery to assess activities of daily living

    Baseline to post-intervention (12-week) change

  • Grip strength

    Measured by handheld dynamometer

    Baseline to post-intervention (12-week) change

Secondary Outcomes (11)

  • Body Mass Index (BMI)

    Baseline to post-intervention (12-week) change

  • Body composition and Muscle Mass

    Baseline to post-intervention (12-week) change

  • Muscle Mass

    Baseline to post-intervention (12-week) change

  • Aerobic fitness

    Baseline to post-intervention (12-week) change

  • Physical activity

    Baseline to post-intervention (12-week) change

  • +6 more secondary outcomes

Other Outcomes (4)

  • Study Feasibility - Participant Accrual

    Captured over the 12-week study period

  • Study Feasibility - Participant Attrition

    Captured over the 12-week study period

  • Study Feasibility - Participant Adherence

    Captured over the 12-week study period

  • +1 more other outcomes

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

12-week circuit-based resistance exercise

Behavioral: Circuit-based resistance exercise (CRT)

Wait-list Control

NO INTERVENTION

Standard of care wait-list control group

Interventions

Circuit-based resistance exercise (CRT)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.

Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35507403DERIVED

MeSH Terms

Conditions

Brain NeoplasmsMotor ActivityMuscular Diseases

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehaviorMusculoskeletal DiseasesNeuromuscular Diseases

Study Officials

  • Scott Grandy, PhD

    Dahousie University and Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

  • Mary MacNeil, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: RCTwith 1:1 allocation to intervention or wait-list control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 10, 2021

Study Start

March 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)