NCT04547634

Brief Summary

The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
3 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

August 17, 2020

Last Update Submit

April 2, 2026

Conditions

Keywords

canceroncologyMetastasissurvivorsExercise TherapyTherapeuticsComplementary Therapiescovid-19

Outcome Measures

Primary Outcomes (5)

  • Suitability of exercise intensity

    Patients are asked before each session to mark in a numerical scale how are they feeling that day to push themselves and get their session well done. From 0 (very well) to 10 (very badly). Higher scores mean a worse feeling.

    Through study completion, an average of 3 months

  • Verification of exercise intensity

    Patients are asked to score the feeling of perceived effort after the session with the Borg Perceived Exertion scale (6-20). Higher scores mean a worse perceived exertion.

    Through study completion, an average of 3 months

  • Total attendance

    Total of days of attendance

    After intervention, an average of 3 months

  • Absence type

    Reasons of absence, categorized as: personal matter, visit the oncology, medical appointment (no related to oncology treatment), health problem, connection problem or unknown.

    Through study completion, an average of 3 months

  • Attendance type

    Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem

    Through study completion, an average of 3 months

Secondary Outcomes (6)

  • Change from Cancer-Related Fatigue (CRF)

    Prior and after intervention, an average of 3 months

  • Change from Functional capacity

    prior and after intervention, an average of 3 months

  • Change from Upper limb functionality (%)

    prior and after intervention, an average of 3 months

  • Change from Lower limb functionality (%)

    prior and after intervention, an average of 3 months

  • Change from Quality of life (self-reported questionnaire)

    prior and after intervention, an average of 3 months

  • +1 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

The sample will receive of a Therapeutic Exercise and Education programme

Other: Therapeutic Exercise and Education

Control

NO INTERVENTION

Subjects will be told to continue with their normal activity of daily living. After the intervention in the experimental group, the control group will be offered intervention.

Interventions

The intervention will consist of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualized based on the evaluations of muscular strength and endurance. Sessions lasted 1 hour, carried out twice a week, for 12 weeks. This intervention will be complemented by nutritional education.

Experimental

Eligibility Criteria

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

You may qualify if:

  • Metastatic breast patient, gynecological cancer patient, or breast cancer survivor under adjuvant treatment after surgical intervention.
  • Having given informed consent to participate voluntarily in the program and to be in contact via telematics (email or messaging platform).
  • Have a good internet connection
  • Be accompanied by an adult on the day of assessment.
  • Availability to access the computer on during the intervention.

You may not qualify if:

  • Technophobia
  • Domatophobia or self-report of adversity to be at home.
  • Lack of logistical requirements (Internet and lack of skill in its use).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Cuesta Vargas

Málaga, Spain

Location

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasmsCOVID-19

Interventions

Exercise TherapyEducational Status

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Researcher of CTS631 University of Malaga

Study Record Dates

First Submitted

August 17, 2020

First Posted

September 14, 2020

Study Start

October 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations