Clinical and Functional Variables in Oncology
- Conditions
- CancerCancer, MetastaticSurvivorship
- Interventions
- Other: Therapeutic Exercise and Education
- Registration Number
- NCT03879096
- Lead Sponsor
- University of Malaga
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Therapeutic Exercise and Education The sample will receive of a Therapeutic Exercise and Education programme
- Primary Outcome Measures
Name Time Method Change from Cancer-Related Fatigue (CRF) Prior and after intervention, an average of 3 months The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used
Change from Upper limb functionality (%) prior and after intervention, an average of 3 months the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled
Change from Lower limb functionality(%) prior and after intervention, an average of 3 months the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled
Change from Functional capacity prior and after intervention, an average of 3 months It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
- Secondary Outcome Measures
Name Time Method Body Composition prior and after intervention, an average of 3 months BMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A
Change fromQuality of life (self-reported questionnaire) prior and after intervention, an average of 3 months 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
Change from specific Breast Cancer Quality of life (self-reported questionnaire) prior and after intervention, an average of 3 months It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23)
Change from Grip Strength (dynamometry) prior and after intervention, an average of 3 months maximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg)
Change from fat mass prior and after intervention, an average of 3 months The fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Change from lean mass prior and after intervention, an average of 3 months The lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Change from water balance prior and after intervention, an average of 3 months Water weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Change from Muscle thickness prior and after intervention, an average of 3 months In biceps and cuadriceps muscles, both during relaxation and contraction.
Change from Basal Metabolism prior and after intervention, an average of 3 months the number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A
Change from Body Mass Index prior and after intervention, an average of 3 months Body Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2)
Change from Physical activity (METS) prior and after intervention, an average of 3 months The International Physical Activity Questionnaire-Short Form (IPAQ-SF) questionnaire will be employed
Change from Handgrip Strength (Kg) prior and after intervention, an average of 3 months Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001
Trial Locations
- Locations (1)
Antonio Cuesta Vargas
🇪🇸Málaga, Spain