CClinicalTrials.gg
CompletedNCT03879096OncolabUpdated Dec 1, 2023

Clinical and Functional Variables in Oncology

An interventional study of Therapeutic Exercise and Education in Cancer, Metastatic, Cancer and Survivorship, sponsored by University of Malaga. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled May 2016, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Cancer, Metastatic
  • Cancer
  • Survivorship

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Keywords

  • cancer
  • oncology
  • Metastasis
  • survivors
  • Exercise Therapy
  • Therapeutics
  • Complementary Therapies
  • fatigue
  • assesment
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 120 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

University of Malaga is the lead sponsor of 118 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Experimental

    The sample will receive of a Therapeutic Exercise and Education programme

    Other: Therapeutic Exercise and Education

Interventions

  • OtherTherapeutic Exercise and Education

    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.

06

What researchers measure

Primary outcomes

  1. Change from Cancer-Related Fatigue (CRF)

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

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

  2. Change from Functional capacity

    It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.

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

  3. Change from Upper limb functionality (%)

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

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

  4. Change from Lower limb functionality(%)

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

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

Secondary outcomes

  1. Body Composition

    BMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A

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

  2. Change from Body Mass Index

    Body Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2)

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

  3. Change from Basal Metabolism

    the number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A

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

  4. Change from fat mass

    The fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

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

  5. Change from lean mass

    The lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

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

  6. Change from water balance

    Water weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

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

  7. Change from Physical activity (METS)

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

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

  8. Change from Handgrip Strength (Kg)

    Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001

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

  9. 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

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

  10. 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)

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

  11. Change from Muscle thickness

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

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

  12. Change from Grip Strength (dynamometry)

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

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

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Study locations

1 site
  • Antonio Cuesta Vargas
    Málaga, Spain
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References and documents

Publications

  • Quinten C, Maringwa J, Gotay CC, Martinelli F, Coens C, Reeve BB, Flechtner H, Greimel E, King M, Osoba D, Cleeland C, Ringash J, Schmucker-Von Koch J, Taphoorn MJ, Weis J, Bottomley A. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011 Dec 21;103(24):1851-8. doi: 10.1093/jnci/djr485. Epub 2011 Dec 7. PubMed 22157640 ↗
  • Cuesta-Vargas AI, Buchan J, Arroyo-Morales M. A multimodal physiotherapy programme plus deep water running for improving cancer-related fatigue and quality of life in breast cancer survivors. Eur J Cancer Care (Engl). 2014 Jan;23(1):15-21. doi: 10.1111/ecc.12114. Epub 2013 Aug 16. PubMed 23947581 ↗
  • Dethlefsen C, Lillelund C, Midtgaard J, Andersen C, Pedersen BK, Christensen JF, Hojman P. Exercise regulates breast cancer cell viability: systemic training adaptations versus acute exercise responses. Breast Cancer Res Treat. 2016 Oct;159(3):469-79. doi: 10.1007/s10549-016-3970-1. Epub 2016 Sep 6. PubMed 27601139 ↗
  • Cuesta-Vargas AI, Carabantes F, Caracuel Z, Conejo I, Alba E. Effectiveness of an individualized program of muscular strength and endurance with aerobic training for improving germ cell cancer-related fatigue in men undergoing chemotherapy: EFICATEST study protocol for a randomized controlled trial. Trials. 2016 Jan 5;17:8. doi: 10.1186/s13063-015-1143-x. PubMed 26732120 ↗
  • Cantarero-Villanueva I, Fernandez-Lao C, Diaz-Rodriguez L, Cuesta-Vargas AI, Fernandez-de-las-Penas C, Piper BF, Arroyo-Morales M. The Piper Fatigue Scale-Revised: translation and psychometric evaluation in Spanish-speaking breast cancer survivors. Qual Life Res. 2014 Feb;23(1):271-6. doi: 10.1007/s11136-013-0434-5. Epub 2013 May 22. PubMed 23695719 ↗
  • Roldan-Jimenez C, Bennett P, Cuesta-Vargas AI. Muscular Activity and Fatigue in Lower-Limb and Trunk Muscles during Different Sit-To-Stand Tests. PLoS One. 2015 Oct 27;10(10):e0141675. doi: 10.1371/journal.pone.0141675. eCollection 2015. PubMed 26506612 ↗
  • Gerritsen JK, Vincent AJ. Exercise improves quality of life in patients with cancer: a systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2016 Jul;50(13):796-803. doi: 10.1136/bjsports-2015-094787. Epub 2015 Dec 30. PubMed 26719503 ↗
  • Escriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Garcia-Almeida JM, Roldan-Jimenez C, Cuesta-Vargas AI. Responsiveness of the new index muscular echotexture in women with metastatic breast cancer: an exercise intervention study. Sci Rep. 2022 Sep 7;12(1):15148. doi: 10.1038/s41598-022-19532-7. PubMed 36071122 ↗
  • Roldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31. PubMed 34463835 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03879096
Lead sponsor
University of Malaga
Responsible party
Dr. Antonio I Cuesta-Vargas (Principal Researcher of CTS631 University of Malaga, University of Malaga) — Principal investigator
First posted
Mar 18, 2019
Start date
May 1, 2016
Primary completion
May 1, 2023
Completion
May 31, 2023
Last update
Dec 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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