Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Diagnosed with Malignant Glioma | Experimental | Patients will participate in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Atkins Diet | Behavioral | The Atkins diet is a low-carb eating plan that focuses on balancing protein, fat, and carbohydrates. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Form (SF)-36 Version 2 Score | The SF-36 | Baseline, Week 12 |
| Number of Participants who Complete Full 12-Week Program | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Ketone Levels | Baseline, Week 12 | |
| Change in Resting Heart Rate | Baseline, Week 12 | |
| Change in 400-meter Walk Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lee Tessler, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Deidentified data will not be shared with other researchers
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fitness Program | Behavioral | 12 weeks of two weekly supervised exercise sessions combined with an individualized home exercise program based on physical capabilities and available equipment. |
|
Time to complete 400-meter-long distance corridor walk. |
| Baseline, Week 12 |
| Change in 1 Repetition Maximum (1RM) - Chest Press | The 1RM for chest press is the maximum weight an individual can perform for a chest press for one repetition. | Baseline, Week 12 |
| Change in 1 Repetition Maximum (1RM) - Leg Press | The 1RM for chest press is the maximum weight an individual can perform for a leg press for one repetition. | Baseline, Week 12 |
| Change in Satisfaction With Life Scale (SWLS) Score | 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. | Baseline, Week 12 |
| Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score | 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. | Baseline, Week 12 |
| Change in Hospital Anxiety And Depression Scale (HADS) Score | 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. | Baseline, Week 12 |
| Change in Fatigue Severity Scale (FSS) Score | 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. | Baseline, Week 12 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |