Clinical and Functional Variables in Oncology

Study Overview
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Brief Summary
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The aim is to analyse the effect of a Therapeutic Exercise and Education programme in several clinical and functional outcomes in cancer patient and survivors

Detailed Description
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In the oncology field, both patients and survivors have to face several symptoms, like cancer-related fatigue or pain. Cancer patients also have affected quality of life, lower levels of function and they are at higher risk of weight gain following diagnosis. Given the risk of obesity, both exercise and diet play a key role in recovery from cancer. Hence, the aim of this study is to show the effect of a Therapeutic Exercise and Education programme (TEEP) in clinical and functional, including practical nutritional education in other clinical and functional secondary outcomes in cancer patients and survivors. Variables included are: body composition, mediterranean-diet adherence, quality of life (QoL) and functional outcomes (limb functionality, physical activity, physical function and handgrip strength). Furthermore, laboratory variables like muscle thickness (ecography) and muscle activity (electromyography) were included.

Official Title
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Clinical and Functional Variables in the Assessment of Oncology Patient

Conditions
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Cancer, Metastatic, Cancer, Survivorship

Intervention / Treatment
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* Other: Therapeutic Exercise and Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In the case of survivors: Patient who had been surgically treated for their primary tumour with no evidence of recurrence at the time of recruitment. The inclusion of patients undergoing hormonal treatment radiotherapy or antiHER therapy will be allowed. In the case of cancer patients: patient who had been dignosed by cancer. In both cases, all participants have to maintain the minimum physical function to perform exercise in group. Exclusion Criteria: Patients were excluded if they had suffered any cardiovascular event defined as stable or unstable angor, acute pulmonary edema, cardiac rhythm disorders, or syncope of cause not affiliated in the year prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The sample will receive of a Therapeutic Exercise and Education programme | Other: Therapeutic Exercise and Education<br>* Intervention will consisted of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualised based on the evaluations of muscular strength and endurance as well as the determination of the aerobic-anaerobic zone transition. Sessions lasted 1 hour, carried out twice a week, during 12 weeks. This intervention will be complemented by nutritional education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Cancer-Related Fatigue (CRF) | The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used | Prior and after intervention, an average of 3 months | 
| Change from Functional capacity | It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed. | prior and after intervention, an average of 3 months | 
| Change from Upper limb functionality (%) | the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled | prior and after intervention, an average of 3 months | 
| Change from Lower limb functionality(%) | the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled | prior and after intervention, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | BMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A | prior and after intervention, an average of 3 months | 
| Change from Body Mass Index | Body Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2) | prior and after intervention, an average of 3 months | 
| Change from Basal Metabolism | the number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A | prior and after intervention, an average of 3 months | 
| Change from fat mass | The fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A | prior and after intervention, an average of 3 months | 
| Change from lean mass | The lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A | prior and after intervention, an average of 3 months | 
| Change from water balance | Water weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A | prior and after intervention, an average of 3 months | 
| Change from Physical activity (METS) | The International Physical Activity Questionnaire-Short Form (IPAQ-SF) questionnaire will be employed | prior and after intervention, an average of 3 months | 
| Change from Handgrip Strength (Kg) | Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001 | prior and after intervention, an average of 3 months | 
| Change fromQuality of life (self-reported questionnaire) | It will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 | prior and after intervention, an average of 3 months | 
| Change from specific Breast Cancer Quality of life (self-reported questionnaire) | It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23) | prior and after intervention, an average of 3 months | 
| Change from Muscle thickness | In biceps and cuadriceps muscles, both during relaxation and contraction. | prior and after intervention, an average of 3 months | 
| Change from Grip Strength (dynamometry) | maximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg) | prior and after intervention, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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assesment, cancer, oncology, Metastasis, survivors, Exercise Therapy, Therapeutics, Complementary Therapies, fatigue