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Completed

NCT Number: NCT03879096

Clinical and Functional Variables in Oncology

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

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Key information

Conditions

Cancer, Metastatic Cancer Fatigue Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Survivorship

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Cuesta Vargas

Málaga, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Exercise and Education

Other

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.

Primary outcomes

  1. Change from Cancer-Related Fatigue (CRF)

    Time frame: Prior and after intervention, an average of 3 months

    The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used

  2. Change from Functional capacity

    Time frame: 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.

  3. Change from Upper limb functionality (%)

    Time frame: prior and after intervention, an average of 3 months

    the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled

  4. Change from Lower limb functionality(%)

    Time frame: prior and after intervention, an average of 3 months

    the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled

Secondary outcomes

  1. Body Composition

    Time frame: 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

  2. Change from Body Mass Index

    Time frame: 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)

  3. Change from Basal Metabolism

    Time frame: 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

  4. Change from fat mass

    Time frame: 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

  5. Change from lean mass

    Time frame: 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

  6. Change from water balance

    Time frame: 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

  7. Change from Physical activity (METS)

    Time frame: prior and after intervention, an average of 3 months

    The International Physical Activity Questionnaire-Short Form (IPAQ-SF) questionnaire will be employed

  8. Change from Handgrip Strength (Kg)

    Time frame: prior and after intervention, an average of 3 months

    Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001

  9. Change fromQuality of life (self-reported questionnaire)

    Time frame: 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

  10. Change from specific Breast Cancer Quality of life (self-reported questionnaire)

    Time frame: 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)

  11. Change from Muscle thickness

    Time frame: prior and after intervention, an average of 3 months

    In biceps and cuadriceps muscles, both during relaxation and contraction.

  12. Change from Grip Strength (dynamometry)

    Time frame: prior and after intervention, an average of 3 months

    maximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg)

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Clinical and Functional Variables in the Assessment of Oncology Patient

Acronym: Oncolab

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2019
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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