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Pilot feasibility study of Exercise in grade III and IV High Grade Glioma (glioblastoma & anaplastic astrocytomas) while undergoing up-front Radiation with or without chemotherapy (EGGR study)

Pilot feasibility study of Exercise in grade III and IV High Grade Glioma (glioblastoma & anaplastic astrocytomas) while undergoing up-front Radiation with or without chemotherapy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000874415
Acronym
EGGR
Enrollment
19
Registered
2016-07-05
Start date
2015-01-20
Completion date
2018-10-04
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot study will evaluate the feasibility and safety of a physical activity program in patients who are newly diagnosed with grade III or IV high grade glioma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with grade III or IV high grade glioma. Study details Participants will be allocated to the group depending on participants wishes and abilities , Participants in one group will receive a structured physical activity program plus usual medical care, while the other group will receive usual medical care only. The physical activity program includes 3 x [1hr] supervised sessions per week for 7 weeks followed by once weekly support for weeks 8-14. All participants will be assessed for suitability to determine which group they should go into. Results from this pilot study will guide development of future studies on physical activity intervention programs in brain cancer patients.

Interventions

Usual medical care Plus A fourteen-week structured physical activity programme. - participant will meet a dedicated physiotherapist at the hospital, three times each week (1hr) for seven weeks. After this participant can decide whether to meet face to face or talk over the telephone, weekly, for another seven weeks. (duration of session time depends on participant) - participants are give a brief diary to fill out and a pedometer (a small device that counts the number of steps you take during t

Usual medical care Plus A fourteen-week structured physical activity programme. - participant will meet a dedicated physiotherapist at the hospital, three times each week (1hr) for seven weeks. After this participant can decide whether to meet face to face or talk over the telephone, weekly, for another seven weeks. (duration of session time depends on participant) - participants are give a brief diary to fill out and a pedometer (a small device that counts the number of steps you take during the day). - During the first seven weeks they will take part in a supervised physical activity program at the treating hospital (1hr or shorter if participant is not able to do a full hour). As part of this program they will do some fitness, strength and balance exercises under the supervision of the exercise provider. These exercises are provided individually but may at some time be performed in a group. - If participants are not able to do the activities this can be adapted to them, intensity is individualised for each participant In weeks 8-14 patients receive a one on one supervised exercise session and are expected to perform daily exercise at home (amount of time to what the patient feels comfortable with). From weeks 14-21 patients are required to perform exercise daily at home independently. (this can be similar exercises to what they have been doing or other forms of exercise they feel comfortable with. For the physical activity: a) exercise intensity is measured by the RPE borg Scale. b) exercises are chosen based on the patients level of function. They include a cardio component eg: cycling, walking, treadmill. Strength component and balance. Intervention is individualised for each patient based on their mobility, strength, co-morbidities and desired outcomes of exercise.

Sponsors

Dr Eng-Siew Koh
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Newly diagnosed histologically confirmed grade III or IV high grade glioma Medically fit and recovered from surgical resection Prior to/at commencement of standard radiotherapy +/- chemotherapy (Temozolomide) ECOG Performance status of 0-2. Life expectancy of at least 6 months Willing and able to comply with all study requirements, including ability to attend and complete exercise program, timing and/or nature of required assessments

Exclusion criteria

ECOG performance status of 3 and above or Karnofsky performance status of less than 60 Inability to read and understand English Concurrent illness (including severe infection) or symptoms that may jeopardize the ability of the patient to complete the exercise program outlined in this protocol with reasonable safety - Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026