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

NCT ID: NCT05816187

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2025-09-22

Brief Summary

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.

Detailed Description

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

Conditions

Breast Cancer; Colon Cancer

Keywords

Quality of Life; Therapeutic exercise; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supervised exercise

Therapeutic exercise program based on aerobic work, strength-endurance and self-stretching of 6 weeks duration, in addition to a reinforcement of the usual self-care recommendations.

Group Type: EXPERIMENTAL

Education program on healthy habits

Intervention Type: BEHAVIORAL

6-week supervised educational program.

Usual care

Subjects receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education program on healthy habits

6-week supervised educational program.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Infanta Leonor

OTHER

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Infanta Leonor

Madrid, , Spain

Countries

Spain

Other Identifiers

Internal Code 012-23

Identifier Type: -

Identifier Source: org_study_id