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Clinical and Functional Variables in Oncology

Clinical and Functional Variables in the Assessment of Oncology Patient

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03879096
Acronym
Oncolab
Enrollment
120
Registered
2019-03-18
Start date
2016-05-01
Completion date
2023-05-31
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cancer, Metastatic, Survivorship

Keywords

cancer, oncology, Metastasis, survivors, Exercise Therapy, Therapeutics, Complementary Therapies, fatigue, assesment

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.

Interventions

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.

Sponsors

University of Malaga
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Cancer-Related Fatigue (CRF)Prior and after intervention, an average of 3 monthsThe Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used
Change from Functional capacityprior and after intervention, an average of 3 monthsIt will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
Change from Upper limb functionality (%)prior and after intervention, an average of 3 monthsthe 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 monthsthe Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled

Secondary

MeasureTime frameDescription
Change from lean massprior and after intervention, an average of 3 monthsThe lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Change from water balanceprior and after intervention, an average of 3 monthsWater weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A
Change from Physical activity (METS)prior and after intervention, an average of 3 monthsThe 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 monthsStrength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001
Body Compositionprior and after intervention, an average of 3 monthsBMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A
Change from specific Breast Cancer Quality of life (self-reported questionnaire)prior and after intervention, an average of 3 monthsIt 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 Muscle thicknessprior and after intervention, an average of 3 monthsIn biceps and cuadriceps muscles, both during relaxation and contraction.
Change from Grip Strength (dynamometry)prior and after intervention, an average of 3 monthsmaximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg)
Change fromQuality of life (self-reported questionnaire)prior and after intervention, an average of 3 monthsIt 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 Body Mass Indexprior and after intervention, an average of 3 monthsBody Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2)
Change from Basal Metabolismprior and after intervention, an average of 3 monthsthe number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A
Change from fat massprior and after intervention, an average of 3 monthsThe fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026