- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816187
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arturo Cano
- Phone Number: 34611165586
- Email: arcano01@ucm.es
Study Locations
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-
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Madrid, Spain, 28031
- Hospital Universitario Infanta Leonor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Not Supervised exercise group
Unsupervised intervention group: The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking.
|
The same therapeutic exercise protocol will be scheduled which will be carried out autonomously without supervision with telephone tracking
|
Experimental: supervised without chemotherapy, radiotherapy or hormone treatment
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.
|
6-week supervised educational program.
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Experimental: supervised with chemotherapy, radiotherapy or hormone treatment
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.
|
6-week supervised educational program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Basal, 1.5, 3, 6, 12 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1.5, 3, 6, 12 months follow up
|
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
|
Basal, 1.5, 3, 6, 12 months follow up
|
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.
|
Basal, 1.5, 3, 6, 12 months follow up
|
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. |
Basal, 1.5, 3, 6, 12 months follow up
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Internal Code 012-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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