Clinical trial NCT04348188: Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
Official title: Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Keywords: Quality of life
Terapeutic exercise
Cancer
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Infanta Leonor
First posted: 2020-04-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Health Related Quality of Life: EORTC QLQ-30
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
Secondary outcomes:
measure: Fatigue
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
measure: Funtional capacity
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
measure: Valuation of the measured force
timeFrame: Basal, 1.5, 3, 6, 12 months follow up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
References: