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Clinical Trials/NCT04766593
NCT04766593
Unknown
N/A

Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise on Functionality, Physical Performance, and Respiratory Parameters in Oncology Patients With Dyspnoea

University of Salamanca1 site in 1 country50 target enrollmentMay 1, 2021
ConditionsCancerDyspnea

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Salamanca
Enrollment
50
Locations
1
Primary Endpoint
Dependency level
Last Updated
5 years ago

Overview

Brief Summary

In recent years the survival of cancer patients has increased exponentially. But together with that survival, and due to the different oncological treatments, side effects have also increased significantly. Some of these may be tumor asthenia or dyspnea. The latter can represent a serious health problem, with important limitations for individuals. To control this, we consider that the measures used in conventional clinical practice can be implemented, mainly developed through physical exercise. But we believe that not only this is enough, but we also propose an intervention with a comprehensive perspective from the rehabilitative approach, with the aim of integrating education and training of the oncological patient with dyspnea. We propose to combine the intervention with physical exercise with a re-education in the performance of activities of daily living, within a "Functional Oncological Re-education Program", to see if in this way better results are achieved in clinical practice.

That is why we propose to verify the effects produced by the implementation of a multimodal physical exercise program with a specific autonomy recovery program in comparison with an isolated intervention through physical exercise on the functionality and physical performance in cancer patients with dyspnea . To do this, we proposed an experimental, prospective, randomized study using a parallel scheme of fixed assignment with an experimental group and a control group in patients from the Oncology Hospitalization Unit of the Salamanca University Hospital Complex. 44 participants with dyspnea, who were admitted at the time of inclusion, will be selected through a consecutive sampling. After the baseline evaluation, the participants will be randomized into two groups. The subjects of the experimental group will carry out a Rehabilitation Program in addition to the physical exercise carried out in all the participants. The main variable will be the performance of basic activities of daily living (Barthel scale) and the degree of dyspnea (mMRC scale). In addition, physical performance (SPPB), blood oxygen saturation (pulse oximetry), fear / avoidance of movement / TAMPA scale) and quality of life in cancer patients (ECOG) will be assessed. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with dyspnea.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Eduardo J Fernández Rodríguez

PhD

University of Salamanca

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Dependency level

Time Frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.

Barthel Index: Measure of physical disability with proven validity and reliability, easy to apply and interpret. Useful to assess functional disability in basic activities of daily living (ABVD). It establishes scores from 0 to 100 in which it quantifies the degree of dependence of the individual.

Level of dyspnea

Time Frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.

Medical Research Council de Disnea (mMRC): Its objective is to allow the patient to quantitatively grade their own dyspnea visually and easily. Establishes 5 degrees of dyspnea involvement in activities.

Secondary Outcomes

  • Physical performance(From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.)
  • kinesiophobia(From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.)
  • Performance status(From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.)
  • Blood oxygen saturation(From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.)

Study Sites (1)

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