Clinical trial · Interventional
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
AIM:To evaluate the effectiveness of a therapeutic exercise program (PET) in cancer patients in improving the quality of life and the need for supervision by health professionals during the performance of same after 6 weeks of intervention. DESIGN: Randomized and controlled clinical trial, parallel groups with active control group. With masking of randomization, patient evaluation and analysis of the data. SUBJETS OF STUDY: 58 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (inhibitors of aromatase, tamoxifen). INTERVENTION: both groups the treatment will be a common work-based therapeutic exercise program aerobic, strength-resistance and self-stretching, in addition to a reinforcement in recommendations usual self-care. The study includes two phases, phase of supervised work and phase of tracing. One of the groups will be supervised in the realization of PET for a period of 6weeks and the other group will do it autonomously and without supervision. The patients will be followed for 1 year, with five blind evaluations: at the beginning of the study, after 6 weeks of intervention, 3, 6 and 12 months after the start of the study.MEASUREMENTS: Principal: Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Pre-post intervention measure, 3, 6 and 12 months. Secondary: Cancer-related fatigue evaluated with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Pre-post Measurement intervention, 3, 6 and 12 months. Functional capacity measured with the Test 6 minutes walking test. Pre-post Measurement intervention, 3, 6 and 12 months. Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. Pre-post intervention measure, 3, 6 and 12 months.COST: effectiveness and cost / incremental utility associated to the program wil be estimated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education program on healthy habits | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supervised exercise group
- description
- Supervised intervention group: 3 weekly sessions of 1 hour during 6 weeks of therapeutic exercise in which aerobic physical activity will be combined with exercise strength of different muscle groups plus stretches on a supervised basis and strengthening of self-care.
- interventionNames
- Behavioral: Education program on healthy habits
- type
- ACTIVE_COMPARATOR
- label
- Not supervised exercise group
- description
- Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.
- interventionNames
- Behavioral: Education program on healthy habits
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18-70 years. * Oncological stage I, II or III. * Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2. * Sign informed consent Exclusion Criteria: * Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness). * Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape. * Important neurological disorders that involve impaired balance, coordination, ataxia. * Sporting activity at moderate intensity exceeding 150mnts / week. * Symptomatic anemia. * Fecal incontinence * Patient with a digestive ostomy. * Decompensated heart disease, * Uncontrolled hypertension * Heart failure. * Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom) * Cardio-respiratory pathology that limits physical activity
References
Publications (0)
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