Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise in Oncology Patients With Dyspnoea

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04766593
• Other study ID #: PI 2020 07 547
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: University of Salamanca
• Contact: Eduardo IP Fernández, PhD
• Phone: 699244390
• Email: edujfr[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer
• Dyspnea

Intervention

Other:
• Oncological functional reeducation program
It will consist of the following actions: Prescription of multimodal physical exercise. Retraining in activities of daily living.

Locations

Country	Name	City	State
Spain	Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dependency level	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.	From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Primary	Level of dyspnea	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.	From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary	Physical performance	Short Physical Performance Score (SPPB): The short physical performance battery, validated in our setting for primary health care, is a test specifically designed to predict disabilities and has demonstrated the ability to predict adverse events, dependency, institutionalization, and mortality.	From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary	kinesiophobia	Tampa Scale for Fatigue Associated Kinesiophobia (TSK-F): scale developed to assess fear of movement related to fatigue / pain, having been validated in cancer patients and chronic fatigue syndrome. The 11-item model (TSK-F-11) will be applied.	From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary	Performance status	ECOG scale: it is a practical way to measure the quality of life of an oncology patient, whose life expectancy changes over the course of months, weeks and even days. It was designed by the Eastern Cooperative Oncology Group (ECOG) in the United States and validated by the World Health Organization (WHO). The main function of this scale is to objectify the quality of life of the patient or "performance status".	From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary	Blood oxygen saturation	Pulse oximetry: non-invasive technique that measures the oxygen saturation (Sat O2) of hemoglobin in circulating blood, usually arterial blood, carried out using a pulse oximeter.	From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.