Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients

Universidad Complutense de Madrid

Status: Unknown

Conditions: Breast Cancer; Colon Cancer

Treatments: Behavioral: Education program on healthy habits

Study type: Interventional

Funder types: Other

Identifiers

NCT04348188

20/007-E_TFM

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Supervised exercise group

Experimental 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.

Treatment:

Behavioral: Education program on healthy habits

Not supervised exercise group

Active Comparator group

Description:

Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.

Treatment:

Behavioral: Education program on healthy habits