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Completed

NCT Number: NCT05816187

Efficacy and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Concurrent Treatment.

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

About this study

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. 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 group and control group. Intevention group 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.COST

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education program on healthy habits

Behavioral

6-week supervised educational program.

Primary outcomes

  1. Changes in Health Related Quality of Life: EORTC QLQ-30

    Time frame: 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 outcomes

  1. Fatigue measurement with FACIT-F

    Time frame: 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.

  2. Functional capacity

    Time frame: 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

  3. Force with manual hydraulic dynamometer.

    Time frame: Basal, 1.5, 3, 6, 12 months follow up

    Valuation of the measured force with manual hydraulic dynamometer . The prehensile force exerted during 5 seconds will be measured, it will be done 3 times and the average will be taken.

  4. The five Times Sit to Stand Test (5x Sit-To-Stand Test)

    Time frame: Basal, 1.5, 3, 6, 12 months follow up

    Valuation of the functional lower extremity strength with the The five Times Sit to Stand Test (5x Sit-To-Stand Test), The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back (43-45 cm, 17-18 inches high). Then the instruction is given by asking the test taker to sit on the chair by resting their back. Also, the test taker is instructed to fold their arms across their chest. Then the test taker should be instructed to do sit-to-stand five times, as quickly as possible, at the count of go and without their back or leg resting on the chair between the interval of repetition.

    The lower the time to complete the test the better the outcome of the test.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Hospital Universitario Infanta Leonor

Registry information

Official study title

Study of the Effectiveness and Safety of Supervised Therapeutic Exercise in Cancer Patients With and Without Simultaneous Chemotherapy, Radiotherapy or Hormonal Treatment.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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