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

NCT04766593 | Unknown DMC

• 1 other identifier: PI 2020 07 547
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Dyspnea

Keywords

Cancer; Rehabilitation; Occupational therapy; Dyspnea; Physical exercise

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• 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 Arms (2)

Oncological functional reeducation program

EXPERIMENTAL

It will consist of the following actions: 1. Prescription of multimodal physical exercise: This therapeutic measure will be carried out both in the individuals of the experimental group and in those of the control group. It will be held daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. The sessions were structured according to the recommendations of the American College of Sports Medicine (ACSM) 18, with an initial warm-up (2-3 minutes), a main part (8-12 minutes) and a final cool-down and relaxation (5 minutes). 2. Retraining in activities of daily living: Gradation and simplification of activities and training in energy saving techniques (EAT). Finally, an exhaustive daily record of the activity carried out by the patient will be carried out, from which it will be modified, adapting it to the clinical situation of the patient.

Other: Oncological functional reeducation program

Prescription of multimodal physical exercise

ACTIVE COMPARATOR

This therapeutic measure will be carried out both in the individuals of the experimental group and in those of the control group. It will be held daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. The guideline will be to maintain a multimodal exercise to perform exercises of different characteristics, including aerobic exercises, balance exercises and low-load strength exercises for muscle groups, both in the upper quadrant and the lower quadrant. The sessions were structured according to the recommendations of the American College of Sports Medicine (ACSM) 18, with an initial warm-up (2-3 minutes), a main part (8-12 minutes) and a final cool-down and relaxation (5 minutes).

Other: Oncological functional reeducation program

Interventions

Oncological functional reeducation program OTHER

It will consist of the following actions: 1. Prescription of multimodal physical exercise. 2. Retraining in activities of daily living.

Oncological functional reeducation program; Prescription of multimodal physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, 37001, Spain

Location

Related Publications (1)

• 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.

  PMID: 34225735 DERIVED

MeSH Terms

Conditions

Neoplasms; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Eduardo IP Fernández, PhD

CONTACT

699244390; edujfr@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 23, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)