Clinical trial NCT04766593: Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise in Oncology Patients With Dyspnoea
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Dyspnea
Keywords: Cancer
Rehabilitation
Occupational therapy
Dyspnea
Physical exercise
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: * Inclusion criteria: pathological diagnosis of oncological disease, being admitted at the time of recruitment in the Oncology Unit of CAUSA, presenting dyspnea parameters equal to or greater than "2" points on the Medical Research Council (MRC) scale, a scoring less than 85 points on the Barthel index and having signed an informed consent that indicates the voluntary agreement to participate in the study.
* Exclusion criteria: not having an adequate cognitive state to understand and carry out the orders that are provided (scores lower than 23 points in Mini Mental State Examination, MMSE), present hemoglobin levels lower than 10g / dl, be an active smoker at the time of recruitment.
* Withdrawal criteria: progression of the disease that leads the patient to a terminal situation or death and failure to carry out the follow-up and final evaluation.

Primary outcomes:
measure: Dependency level
timeFrame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
measure: Level of dyspnea
timeFrame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary outcomes:
measure: Physical performance
timeFrame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
measure: kinesiophobia
timeFrame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
measure: Performance status
timeFrame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
measure: Blood oxygen saturation
timeFrame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
References:
citation: Fernandez-Rodriguez EJ, Gonzalez-Sanchez J, Puente-Gonzalez AS, Recio-Rodriguez JI, Sanchez-Gomez C, Mendez-Sanchez R, Cruz-Hernandez JJ, Rihuete-Galve MI. Specific autonomy recovery programme in a comprehensive rehabilitation on functionality and respiratory parameters in oncological patients with dyspnoea. Study protocol. BMC Nurs. 2021 Jul 5;20(1):120. doi: 10.1186/s12912-021-00633-z.