Specific autonomy recovery programme in a comprehensive rehabilitation on functionality and respiratory parameters in oncological patients with dyspnoea. Study protocol.

BACKGROUND: Survival in cancer patients has increased exponentially in recent years, with multiple side effects caused by treatments. Cancer-related asthenia and dyspnea are among them, which represent a serious health problem, with considerable limitations and reduced quality of life. An implementation of the conventional clinical practice, developed through physical exercise, may be useful in controlling dyspnoea. This study aims to compare the effects of a comprehensive rehabilitation implementing a programme of multimodal physical exercise with a specific autonomy recovery programme, versus an isolated intervention using the physical exercise programme alone, on the functionality, physical performance and respiratory parameters in oncologycal patients with dyspnea.
METHODS: This is a protocol por an experimental, prospective, randomized, parallel-controlled clinical trial, with two arms design of fixed assignment with an experimental and control groups. It will conduct in the Oncology Hospitalisation Unit at the University Hospital Complex of Salamanca, using consecutive sampling to select 50 participants with oncological dyspnoea who are hospitalised at the time of inclusion. After baseline assessment, participants will be randomised into the groups. Experimental group will complete Comprehensive Rehabilitation with the autonomy recovery and the multimodal exercise programmes, and in the control group, only the multimodal exercise programme will be carried out. The primary outcomes will be basic activities of daily living (Barthel Index) and degree of dyspnoea (MRC scale). Additionally, physical performance will be evaluated with the Short Physical Performance Battery (SPPB), as will the oxygen saturation in the blood using pulse oximetry, fear/avoidance of movement with the Tampa Scale of Kinesiophobia (TSK), and the quality of life of the oncology patient (ECOG performance scale). DISCUSSION: The results of this study may be translated to clinical practice, incorporating a specific autonomy recovery programme into comprehensive rehabilitation programmes of care for cancer patients with dyspnoea. Increase in the survival of patients with cancer includes multiple side effects as cancer-related asthenia and dyspnea, which represents a serious health problem. The current study addresses to improve the conventional clinical practice by proposing an integral, rehabilitative approach, to implement education and training for oncology patients with dyspnea to increase their quality of life. TRIAL REGISTRATION: ClinicalTrials.gov; ID: NCT04766593 . (February 23, 2021).

RCT Entities:   Population Interventions Outcomes