Fitness and Nutrition in Glioma

Not Applicable

Recruiting

• Conditions: Malignant Glioma

• Registration Number: NCT06665373
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III or IV)
• Karnofsky Performance Status (KPS) ≥ 70%
• Willing to follow the study intervention and follow-up
• Able to give full informed consent

Exclusion Criteria

• Currently undergoing initial concurrent radiation/chemotherapy
• Severe medical co-morbidities
• Any medical condition which prohibits moderate to vigorous physical activity (60-85% HRmax)
• Any medical condition which prohibits a restrictive diet
• Neurological deficit preventing participation in moderate to vigorous physical activity
• Severe psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants who Complete Full 12-Week Program	Week 12
Change in Short Form (SF)-36 Version 2 Score	Baseline, Week 12	The SF-36

Secondary Outcome Measures

Name	Time	Method
Change in Blood Ketone Levels	Baseline, Week 12
Change in Resting Heart Rate	Baseline, Week 12
Change in 400-meter Walk Time	Baseline, Week 12	Time to complete 400-meter-long distance corridor walk.
Change in 1 Repetition Maximum (1RM) - Chest Press	Baseline, Week 12	The 1RM for chest press is the maximum weight an individual can perform for a chest press for one repetition.
Change in 1 Repetition Maximum (1RM) - Leg Press	Baseline, Week 12	The 1RM for chest press is the maximum weight an individual can perform for a leg press for one repetition.
Change in Satisfaction With Life Scale (SWLS) Score	Baseline, Week 12	5-item assessment of satisfaction with life. Each item is rated on a 7-point Likert scale. The total score is the sum of responses and ranges from 5-35; higher scores indicate greater satisfaction.
Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score	Baseline, Week 12	The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score for the Anxiety subscale is the sum of the respective seven items. The total score ranges from 0-21; higher scores indicate greater anxiety.
Change in Hospital Anxiety And Depression Scale (HADS) Score	Baseline, Week 12	The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the items; the total score ranges from 0-42; higher scores indicate greater anxiety and depression.
Change in Fatigue Severity Scale (FSS) Score	Baseline, Week 12	The Fatigue Severity Scale (FSS) is a 9-item questionnaire that measures the severity of fatigue and how it affects a person's lifestyle and activities. Items are rated on a 7-point Likert scale. The total score is the sum of responses and ranges from 9 to 63. A higher score indicates greater fatigue severity.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States