STUDY OF THE EFFECTIVENESS AND SAFETY OF SUPERVISED THERAPEUTIC EXERCISE IN CANCER PATIENTS WITH AND WITHOUT SIMULTANEOUS CHEMOTHERAPY, RADIOTHERAPY OR HORMONAL TREATMENT.
Study Details
Study Description
Brief Summary
OBJECTIVE: To evaluate the effectiveness of a PET scan in oncological patients, with and without simultaneous treatment with chemotherapy, radiotherapy or hormonal therapy, in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention. DESIGN: Randomized controlled clinical trial, parallel groups with active control group. With randomization blinding, patient assessment and data analysis. STUDY SUBJECTS: 78 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (aromatase inhibitors, tamoxifen). INTERVENTION: three treatment groups: supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy, radiotherapy or hormonal treatment, supervised therapeutic exercise group with simultaneous chemotherapy, radiotherapy or hormonal treatment and control group. Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised. Patients will be followed for 1 year, with five blinded assessments: at baseline, after 6 weeks of intervention, 3, 6 and 12 months after baseline. MEASUREMENTS: Main: Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Measured pre-post intervention, 3, 6 and 12 months. Secondary: Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Measured pre-post intervention, 3, 6 and 12 months. Functional capacity measured with the 6-minute walk test. Pre-post intervention measurement, 3, 6 and 12 months. Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test. Pre-post intervention measurement, 3, 6 and 12 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVE: To evaluate the effectiveness of a PET scan in oncological patients, with and without simultaneous treatment with chemotherapy, radiotherapy or hormonal therapy, in improving quality of life and the need for supervision by health professionals during its performance after 6 weeks of intervention. DESIGN: Randomized controlled clinical trial, parallel groups with active control group. With randomization blinding, patient assessment and data analysis. STUDY SUBJECTS: 78 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (aromatase inhibitors, tamoxifen). INTERVENTION: three treatment groups: supervised therapeutic exercise group without supervised therapeutic exercise group without chemotherapy, radiotherapy or hormonal treatment, supervised therapeutic exercise group with simultaneous chemotherapy, radiotherapy or hormonal treatment and control group. Two groups will be supervised in performing PET for a period of 6 weeks and the other group will do it autonomously and unsupervised. Patients will be followed for 1 year, with five blinded assessments: at baseline, after 6 weeks of intervention, 3, 6 and 12 months after baseline. MEASUREMENTS: Main: Quality of life assessed with questionnaire measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Measured pre-post intervention, 3, 6 and 12 months. Secondary: Cancer-related fatigue assessed with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Measured pre-post intervention, 3, 6 and 12 months. Functional capacity measured with the 6-minute walk test. Pre-post intervention measurement, 3, 6 and 12 months. Strength assessment measured with manual hydraulic dynamometer and 5 repetitions of the sit-to-stand test. Pre-post intervention measurement, 3, 6 and 12 months.COST
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: supervised without chemotherapy, radiotherapy or hormone treatment The PET will consist of a common therapeutic exercise program based on aerobic work, strength-endurance and self-stretching of 6 weeks duration, in addition to a reinforcement of the usual self-care recommendations. |
Behavioral: Education program on healthy habits
6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention
|
| Experimental: supervised with chemotherapy, radiotherapy or hormone treatment The PET will consist of a common therapeutic exercise program based on aerobic work, strength-endurance and self-stretching of 6 weeks duration, in addition to a reinforcement of the usual self-care recommendations. |
Behavioral: Education program on healthy habits
6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention
|
| Active Comparator: Not Supervised exercise group Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking. |
Behavioral: Habitual
The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking
|
Outcome Measures
Primary Outcome Measures
- Changes in Health Related Quality of Life: EORTC QLQ-30 [Basal, 1.5, 3, 6, 12 months follow up]
(EORTC QLQ-30). The QLQ-C30 questionnaire is a specific questionnaire for cancer, it is composed of 30 questions or items that assess the quality of life in relation to physical, emotional, social aspects and in general the level of functionality of patients diagnosed with cancer. The QLQ-C30 questionnaire is assigned values between 1 and 4 (1: not at all, 2: a little, 3: a lot, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with score from 1 to 7 (1: bad, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, 0 being the worst possible and 100 the best.
Secondary Outcome Measures
- Fatigue [1.5, 3, 6, 12 months follow up]
Fatigue measurement with FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionaire. The FACIT-F 13-item scale is designed on a 5-point Likert scale (0 = nothing; 1 = little; 2 = something; 3 = a lot; 4 = very much). The FACIT-F scale is designed so that a high score is good, the possible score is 0 to 52, 0 being the worst possible and 52 the best.
- Funcional capacity [Basal, 1.5, 3, 6, 12 months follow up]
The 6-minute walk test consists of measuring the maximum distance that the patient is able to walk in 6 minutes, on a tour short in a hallway, simultaneously assessing heart rate, oxygen saturation and degree of dyspnea. Usually healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex
- Basal, 1.5, 3, 6, 12 months follow up [Basal, 1.5, 3, 6, 12 months follow up]
Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. The test assesses the act of sitting and standing for five repetitions as quickly as possible, in a chair without arms with a seat height of 43 cm. The participant crosses his arms over his chest and sits with his back against the vertical back of the chair. The performance of the test is based on its duration; Consequently, the shorter the time it takes for the patient to perform the test, the better it will be
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 18-70 years.
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Oncological stage I, II or III.
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Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2.
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Sign informed consent
Exclusion Criteria:
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Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness).
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Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape.
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Important neurological disorders that involve impaired balance, coordination, ataxia.
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Sporting activity at moderate intensity exceeding 150mnts / week.
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Symptomatic anemia.
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Fecal incontinence
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Patient with a digestive ostomy.
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Decompensated heart disease,
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Uncontrolled hypertension
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Heart failure.
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Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
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Cardio-respiratory pathology that limits physical activity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Infanta Leonor | Madrid | Spain | 28031 |
Sponsors and Collaborators
- Universidad Complutense de Madrid
- Hospital Universitario Infanta Leonor
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Internal Code 012-23