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Clinical and Functional Variables in Oncology

NCT ID: NCT03879096

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2023-05-31

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.

Conditions

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Cancer, Metastatic Cancer Survivorship

Keywords

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cancer oncology Metastasis survivors Exercise Therapy Therapeutics Complementary Therapies fatigue assesment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

The sample will receive of a Therapeutic Exercise and Education programme

Group Type EXPERIMENTAL

Therapeutic Exercise and Education

Intervention Type 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.

Interventions

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Therapeutic 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Antonio I Cuesta-Vargas

Principal Researcher of CTS631 University of Malaga

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antonio Cuesta Vargas

Málaga, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22157640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23947581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27601139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26732120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23695719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26506612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26719503 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36071122 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34463835 (View on PubMed)

Other Identifiers

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ClubCam

Identifier Type: -

Identifier Source: org_study_id