NCT03879096

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 1, 2023

Status Verified

May 1, 2020

Enrollment Period

7 years

First QC Date

March 11, 2019

Last Update Submit

November 30, 2023

Conditions

Cancer, MetastaticCancerSurvivorship

Keywords

canceroncologyMetastasissurvivorsExercise TherapyTherapeuticsComplementary Therapiesfatigueassesment

Outcome Measures

Primary Outcomes (4)

  • Change from Cancer-Related Fatigue (CRF)

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

    Prior and after intervention, an average of 3 months

  • Change from Functional capacity

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

    prior and after intervention, an average of 3 months

  • Change from Upper limb functionality (%)

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

    prior and after intervention, an average of 3 months

  • Change from Lower limb functionality(%)

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

    prior and after intervention, an average of 3 months

Secondary Outcomes (12)

  • Body Composition

    prior and after intervention, an average of 3 months

  • Change from Body Mass Index

    prior and after intervention, an average of 3 months

  • Change from Basal Metabolism

    prior and after intervention, an average of 3 months

  • Change from fat mass

    prior and after intervention, an average of 3 months

  • Change from lean mass

    prior and after intervention, an average of 3 months

  • +7 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

The sample will receive of a Therapeutic Exercise and Education programme

Other: Therapeutic Exercise and Education

Interventions

Therapeutic Exercise and EducationOTHER

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.

Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Cuesta Vargas

Málaga, Spain

Location

Related Publications (9)

  • 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.

    PMID: 22157640BACKGROUND

  • 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.

    PMID: 23947581BACKGROUND

  • 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.

    PMID: 27601139BACKGROUND

  • 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.

    PMID: 26732120BACKGROUND

  • 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.

    PMID: 23695719BACKGROUND

  • 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.

    PMID: 26506612BACKGROUND

  • 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.

    PMID: 26719503BACKGROUND

  • 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.

    PMID: 36071122DERIVED

  • 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.

    PMID: 34463835DERIVED

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasmsFatigue

Interventions

Exercise TherapyEducational Status

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Researcher of CTS631 University of Malaga

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 18, 2019

Study Start

May 1, 2016

Primary Completion

May 1, 2023

Study Completion

May 31, 2023

Last Updated

December 1, 2023

Record last verified: 2020-05

Locations

ES(1)