NCT05816187Completed
Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment.
Study of the Effectiveness and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Simultaneous Chemotherapy, Radiotherapy or Hormonal Treatment.
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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 INTERVENTION: two treatment groups: supervised therapeutic exercise and control group. Tho groups will be supervised in performing PET for a period of 6 weeks and the other group will receive the usual care. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 3 Apr 2023
- Start date
- 15 Mar 2023
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Universidad Complutense de Madrid
- Diseases
- Colorectal cancer
- NCT number
- NCT05816187
What you commit to
- Study type: Interventional
- Participants enrolled: 78
- From 15 Mar 2023 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Decompensated heart disease,
- Uncontrolled hypertension
- Heart failure.
- Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
Other
- Sporting activity at moderate intensity exceeding 150mnts / week.
- Symptomatic anemia.
- Fecal incontinence
- Patient with a digestive ostomy.
- Cardio-respiratory pathology that limits physical activity
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.