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Clinical Trials/NCT04547634
NCT04547634
Completed
Not Applicable

Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic

University of Malaga2 sites in 1 country30 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Therapeutic Exercise and Education
Conditions
Cancer Metastatic
Sponsor
University of Malaga
Enrollment
30
Locations
2
Primary Endpoint
Suitability of exercise intensity
Status
Completed
Last Updated
24 days ago

Overview

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

Detailed Description

Current literature shows that Therapeutic Exercise has multiple benefits in oncology patients, such as improvements in function and quality of life, and ameliorates symptoms such as cancer-related fatigue. Furthermore, given the risk of obesity, both exercise and diet play a key role in recovery from cancer. In fact, current guidelines support the use of exercise with therapeutic purposes as a complement to cancer treatment. As a consequence of the COVID-19 pandemic, oncology patients present more difficulties to attend programs, as the vast majority are immunosuppressed, and they are considered risk population. Therefore, new online (TEEP) must be developed to facilitate the benefits of these programs in the post-COVID Era. This study analyses the feasibility (in terms of suitability and verification of exercise prescription, absence and attendance type, and total days of attendance) and the effect (in weight, physical function, and symptoms) in cancer patients and survivors.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
December 1, 2024
Last Updated
24 days ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Antonio I Cuesta-Vargas

Principal Researcher of CTS631 University of Malaga

University of Malaga

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Arms & Interventions

Experimental

The sample will receive of a Therapeutic Exercise and Education programme

Intervention: Therapeutic Exercise and Education

Control

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.

Outcomes

Primary Outcomes

Suitability of exercise intensity

Time Frame: Through study completion, an average of 3 months

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.

Verification of exercise intensity

Time Frame: Through study completion, an average of 3 months

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.

Total attendance

Time Frame: After intervention, an average of 3 months

Total of days of attendance

Absence type

Time Frame: Through study completion, an average of 3 months

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

Attendance type

Time Frame: Through study completion, an average of 3 months

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

Secondary Outcomes

  • Change from Upper 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)
  • 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 Lower limb functionality (%)(prior and after intervention, an average of 3 months)
  • Change from specific Breast Cancer Quality of life (self-reported questionnaire)(prior and after intervention, an average of 3 months)

Study Sites (2)

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