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| Name | Class |
|---|---|
| Universidad Europea de Madrid | OTHER |
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Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.
Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.
The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.
After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.
Secondary objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Supervised combined training | Experimental | INTERVENTION: Two supervised 75 min-vigorous aerobic training & strength training |
|
| B: Supervised strength training | Active Comparator | ACTIVE COMPARATOR: Two supervised 45-minute sessions of strength training & Participants will be advised to comply with international recommendations of physical activity (150 min pf MVPA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigorous aerobic training | Behavioral | Supervised vigorous aerobic training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in cancer related-fatigue | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cardiorespiratory fitness | measured through CPET | 4 months |
| Changes in quality of life | measured through EORTC QLQ C30 | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itziar Pagola, PhD | Universidad Europea de Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro-Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 20, 2019 | |
| Reset | Jul 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 20, 2019 | Jul 8, 2019 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| adherence to the program | 4 months |
| adherence to international recommendations | measured by accelerometer | 4 months |
| Changes in body composition | measured by DEXA (Dual Energy X-Ray Absortiometry) | 4 months |
| Employment status | 4 months |