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

Primary Purpose

Cancer, Dyspnea

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oncological functional reeducation program
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Rehabilitation, Occupational therapy, Dyspnea, Physical exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • 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.

Sites / Locations

  • Universidad de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oncological functional reeducation program

Prescription of multimodal physical exercise

Arm Description

It will consist of the following actions: 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). 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.

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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".
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.

Full Information

First Posted
February 16, 2021
Last Updated
April 7, 2021
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT04766593
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Dyspnea
Keywords
Cancer, Rehabilitation, Occupational therapy, Dyspnea, Physical exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oncological functional reeducation program
Arm Type
Experimental
Arm Description
It will consist of the following actions: 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). 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.
Arm Title
Prescription of multimodal physical exercise
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Oncological functional reeducation program
Intervention Description
It will consist of the following actions: Prescription of multimodal physical exercise. Retraining in activities of daily living.
Primary Outcome Measure Information:
Title
Dependency level
Description
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.
Time Frame
From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Title
Level of dyspnea
Description
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.
Time Frame
From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary Outcome Measure Information:
Title
Physical performance
Description
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.
Time Frame
From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Title
kinesiophobia
Description
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.
Time Frame
From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Title
Performance status
Description
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".
Time Frame
From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Title
Blood oxygen saturation
Description
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.
Time Frame
From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo IP Fernández, PhD
Phone
699244390
Email
edujfr@usal.es
Facility Information:
Facility Name
Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37001
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo IP Fernández, PhD
Phone
699244390
Email
edujfr@usal.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34225735
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.
Results Reference
derived

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

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