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Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney

Primary Purpose

Occupational Therapy, Cancer, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Comprehensive functional care plan
Traditional intervention without rehabilitation
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Occupational Therapy focused on measuring Occupational Therapy, Cancer, Dyspnea

Eligibility Criteria

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

Inclusion Criteria:

  • Have an anatomopathological diagnosis of cancer disease among the reasons for admission.
  • Present at least some level 2 or moderate dyspnea parameters on the MRC scale.
  • Be admitted to the University Hospital of Salamanca.
  • Sign an informed consent authorizing their voluntary participation in the study.

Exclusion Criteria:

  • Present a diagnosis of bone metastases.
  • Not having an adequate cognitive state to understand and carry out the orders provided.
  • Carry out a number of rehabilitation sessions of less than 5.
  • Present hemoglobin levels below 10g / dl.
  • To be an active smoker today.
  • Present pleural effusion.
  • Present febrile neutropenia.

Sites / Locations

  • Eduardo José Fernández

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive functional care plan

Traditional intervention without rehabilitation

Arm Description

The intervention will be carried out thanks to the "reeducation to the effort" carried out in the individuals, which will have the following interventions: The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.

Nursing care. Medical care. Spiritual attention.

Outcomes

Primary Outcome Measures

Dyspnoea
MRC scale

Secondary Outcome Measures

Activities of Daily Living
Barthel index

Full Information

First Posted
September 3, 2019
Last Updated
March 25, 2020
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT04186754
Brief Title
Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney
Official Title
Interdisciplinary Randomized Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

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
Hypothesis: Oncological patients presenting with respiratory problems will benefit both at a functional level and at a level of quality of life from the inclusion of a program of integral respiratory rehabilitation from the perspective of nursing and occupational therapy at the time of admission hospital for an exacerbation of his respiratory symptoms. Main objective: to verify the effectiveness of a comprehensive respiratory rehabilitation program carried out from the perspective of an interdisciplinary team made up of nurses, occupational therapists and doctors in the improvement of the respiratory problem referred to oncological disease. Design: experimental, randomized, stratified, longitudinal prospective study through a parallel scheme of fixed assignment with experimental group and control group.
Detailed Description
Hypothesis: Oncological patients presenting with respiratory problems will benefit both at a functional level and at a level of quality of life from the inclusion of a program of integral respiratory rehabilitation from the perspective of nursing and occupational therapy at the time of admission hospital for an exacerbation of his respiratory symptoms. Main objective: to verify the effectiveness of a comprehensive respiratory rehabilitation program carried out from the perspective of an interdisciplinary team made up of nurses, occupational therapists and doctors in the improvement of the respiratory problem referred to oncological disease. Design: experimental, randomized, stratified, longitudinal prospective study through a parallel scheme of fixed assignment with experimental group and control group. Location: Medical Oncology Service of the University Hospital of Salamanca. PROCESS The study will be carried out in accordance with the provisions of the Medical Oncology Service of the University Hospital of Salamanca. Prior authorization by the patient after informed consent read, understood and signed will proceed to randomization. The subjects will be assigned prospectively, to the study, through a randomization process, using random numbers generated by computer, to the two conditions of the study: Control condition: Group I and Experimental condition: Group II. In the generated table, those individuals that correlate with an odd number will be assigned to the control condition, while on the contrary, those with even numbers will correspond to the experimental group. In the first, the control group will proceed to carry out an exhaustive evaluation at the time of admission and at the time of discharge, which will consist of: BODE index, which measures muscle mass index (BMI), dyspnea level by Medical Research Council scale, exercise capacity by 6-minute walk test and forced expiratory volume during the first second (FEV1); With all this data the investigators will establish a score in this index. The investigators will also value activities of daily living (AVD), thanks to the BARTHEL index and Health Related Quality of Life (HRQOL) thanks to the EuroQol-5D. Finally, the investigators will take into account a series of intervening variables collected in a database, previously prepared solely and exclusively for the realization of this project. In the second, the experimental group, in addition to performing the same assessment, upon admission and discharge, as in the control group, will be carried out with each individual sessions of Integral Respiratory Rehabilitation, by professionals from the disciplines of nursing and occupational therapy, on a daily basis with an approximate duration of 30-45 minutes. INTEGRAL RESPIRATORY REHABILITATION PROGRAM The work methodology used will follow the theoretical basis of Rehabilitation based on functional integration. It is a new method of intervention in patients in acute and subacute phase, based fundamentally on "treating dysfunction with function". It emerged to respond to the continuing demands of patients and caregivers in the geriatric service, oriented towards the need to achieve greater patient independence. There was a demotivation of the patients towards the performance of conventional therapeutic treatments focused on the deficit. For this, it was necessary to create a new intervention method that would achieve the greatest possible functionality in the shortest period of time (stays in very mild acute units), seeking much more effective, fast and dynamic treatments. Functional mobility will be the central axis of the treatment. With this type of intervention, the reinforcement of the patient's functional gain will be immediate, so that both he and his family / caregiver will be more involved with the treatment. It can be said that the level of collaboration increases, ensuring that during the rest of the day, in which the patient does not receive interventions, the benefits obtained continue to be enhanced (this is what the investigators call 24-hour therapy), stimulating and mobilizing the patient outside of the room (wandering around, in a wheelchair ...) taking it to the bathroom, letting them eat alone ... in short, promoting their independence and preventing the respiratory patient cycle from being fulfilled, which will lead to loss of functionality resulting from dyspnea that will secondarily worsen the quality of individual's life The intervention will be carried out thanks to the "reeducation to the effort" carried out in the individuals, which will have the following interventions: Progressive mobilization. Gradation and simplification of activities. Teaching energy saving techniques. Modification of daily activities. Breathing exercises. Airway permeabilization techniques.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive functional care plan
Arm Type
Experimental
Arm Description
The intervention will be carried out thanks to the "reeducation to the effort" carried out in the individuals, which will have the following interventions: The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.
Arm Title
Traditional intervention without rehabilitation
Arm Type
Active Comparator
Arm Description
Nursing care. Medical care. Spiritual attention.
Intervention Type
Procedure
Intervention Name(s)
Comprehensive functional care plan
Intervention Description
The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.
Intervention Type
Procedure
Intervention Name(s)
Traditional intervention without rehabilitation
Intervention Description
Clinical control by nursing professionals and exclusively pharmacological treatment
Primary Outcome Measure Information:
Title
Dyspnoea
Description
MRC scale
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Activities of Daily Living
Description
Barthel index
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Have an anatomopathological diagnosis of cancer disease among the reasons for admission. Present at least some level 2 or moderate dyspnea parameters on the MRC scale. Be admitted to the University Hospital of Salamanca. Sign an informed consent authorizing their voluntary participation in the study. Exclusion Criteria: Present a diagnosis of bone metastases. Not having an adequate cognitive state to understand and carry out the orders provided. Carry out a number of rehabilitation sessions of less than 5. Present hemoglobin levels below 10g / dl. To be an active smoker today. Present pleural effusion. Present febrile neutropenia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo IP Fernández, OT
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eduardo José Fernández
City
Salamanca
ZIP/Postal Code
37900
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A specific database will be created to which any external researcher can access after contact by email to the email edujfr@usal.es
IPD Sharing Time Frame
We do not establish a specific period of time, access will be permanent.
IPD Sharing Access Criteria
Researcher upon invitation by mail

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Study of an Integral Respiratory Rehabilitation Program in Oncological Patient With Disney

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