Efficacy Of An Education Plan And Adherence Follow-Up To The Exercise In Patients With COPD

NCT05204498 | Completed DMC

• 1 other identifier: 0002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease is one of the main causes of morbidity and mortality worldwide, according to recent publications of the World Health Organization, its main feature is the response to noxious particles of gases, which trigger an inflammatory response with its sequence secondary to the flow of air, the limitation generated by the ventilation reserve mechanism of insufficiency, dyspnea and dysfunction at the muscular level, these limitations generate a high degree of disability worldwide in the different areas of the people who suffer from it, which it affects their basic performance and their interaction with the environment. The World Health Organization, in a more recent projection, predicted that COPD will increase from its recent classification as the fifth most common cause of mortality to the fourth most common cause by 2030, which would place it behind ischemic cerebrovascular disease, HIV / AIDS and heart disease. More importantly, COPD is a cause that increases chronic disability and is expected to become the fifth most common cause of chronic disability worldwide by 2020. There is great evidence on the benefit of pulmonary rehabilitation in patients with COPD, which generates changes among which is tolerance to exercise, dyspnea, control of symptoms and improvement in the quality of life related to health. It should be noted that pulmonary rehabilitation not only includes physical training, but also involves the educational component in relation to healthy habits. In this way, patients who have achieved a successful form of a pulmonary rehabilitation program must obtain an improvement in their physical and psychological state, following up on this type of patients, achieving the empowerment of the health process and improving long-term symptoms and healthy lifestyle habits. Therefore, the objective of this study is to carry out a telephone education and a follow-up plan that emphasizes the importance of physical activity with adequate parameters to be part of the lifestyle of patients and to comply with the activity.

Conditions

Patient Adherence

Keywords

chronic obstructive pulmonary disease; dyspnea; exercise tolerance; Education

Outcome Measures

Primary Outcomes (3)

• Adherence to exercise

  practicing physical activity as a principle of self-determination and converting it into a healthy lifestyle or habit and aerobic capacity will be measured by completing 85% of sessions (21 sessions) of pulmonary rehabilitation, including education and telephone follow-up.

  Measured at the end of the 8 week monitoring

• knowledge of the disease

  Faculty of the human being to understand the aspects related to his illness, the measurement of the needs in education will be carried out through the LINQ Lung Information Needs Questionnaire.

  Measured at the end of the 8 week monitoring

• health-related quality of life

  A generic concept that reflects the concern for the modification and improvement of the attributes of life, for example, the physical, political, moral, social environment, as well as health and disease. It is applied with the Saint George's Questionnaire (SGRQ), this scale goes from 0 to 100 points, high scores indicate that the patient is unwell and low scores the patient is better and a decrease of 4 points after an intervention is considered clinically significant.

  Measured at the end of the 8 week monitoring

Study Arms (2)

Education plan

EXPERIMENTAL

Education plan and adherence to exercise Educational talk about the importance of exercise as an important strategy to change dyspnea at the start of the study. Twice a week, corresponding to the days that do not attend the sessions of pulmonary rehabilitation, calls will be made with a duration of 15 minutes each, in the calls will encourage and guide the practice of physical activity and breathing exercises

Behavioral: Education plan and adherence to exercise

control

NO INTERVENTION

A survey will be conducted at week 8 of monitoring where adherence to exercise is measured during the 8-week study. At the end of week 8, patients will be referred to the pulmonary rehabilitation unit in order to evaluate the anthropometric parameters, assess dyspnea with the modified Medical Research Council scale, the hospital anxiety and depression scale, the Saint George respiratory questionnaire, the pulmonary information needs questionnaire and the 6-minute walk test again.

Interventions

Education plan and adherence to exercise BEHAVIORAL

Through phone calls with a motivating sense at any time of the day, twice a week. * It will be recorded in an Excel table each time the patient is called. * A monthly survey will be applied where the adherence to the exercise during the previous month is measured. * These activities will be carried out for 8 weeks. At the end of week 8, patients will be referred to the pulmonary rehabilitation unit to evaluate the anthropometric parameters, assess dyspnea with the modified scale of the Medical Research Council, the hospital anxiety and depression scale, the Saint George respiratory questionnaire , the pulmonary information You need the questionnaire and the 6-minute walk test again.

Education plan

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients clinically stable
• Optimised medical therapy
• Patients who perform pulmonary rehabilitation for the first time
• Postbronchodilator FEV1 \< 60% pred and FEV1/forced vital capacity (FVC) \< 70% whithout significant reversibility (\< 15% change un unutial FEV1)

You may not qualify if:

• Clinical evidence of exercise limiting cardiovascular
• Clinical evidence of neuromuscular diseases

Sponsors & Collaborators

• Clínica de Occidente S.A: lead

Study Sites (1)

Juan Carlos Avila

Cali, Valle del Cauca Department, 32, Colombia

Location

Related Publications (15)

• Hill K, Vogiatzis I, Burtin C. The importance of components of pulmonary rehabilitation, other than exercise training, in COPD. Eur Respir Rev. 2013 Sep 1;22(129):405-13. doi: 10.1183/09059180.00002913.

  PMID: 23997066 BACKGROUND

• Ávila-Valencia, J. C., Muñoz-Erazo, B. E., Sarria, V., Cordoba, V. B., & Betancourt-Peña, J. (2017). Cambios en el Bode-Bodex de pacientes con EPOC al culminar un programa de rehabilitación pulmonar. Revista colombiana de rehabilitacion, 15(1), 40-47.

  BACKGROUND

• Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9. doi: 10.1183/09031936.02.01152001.

  PMID: 12166558 BACKGROUND

• Mesquita R, Meijer K, Pitta F, Azcuna H, Goertz YMJ, Essers JMN, Wouters EFM, Spruit MA. Changes in physical activity and sedentary behaviour following pulmonary rehabilitation in patients with COPD. Respir Med. 2017 May;126:122-129. doi: 10.1016/j.rmed.2017.03.029. Epub 2017 Mar 31.

  PMID: 28427543 BACKGROUND

• Naseer BA, Al-Shenqiti AM, Ali AH, Al-Jeraisi TM, Gunjan GG, Awaidallah MF. Effect of a short term pulmonary rehabilitation programme on exercise capacity, pulmonary function and health related quality of life in patients with COPD. J Taibah Univ Med Sci. 2017 Aug 23;12(6):471-476. doi: 10.1016/j.jtumed.2017.07.005. eCollection 2017 Dec.

  PMID: 31435281 BACKGROUND

• Richards J, Hillsdon M, Thorogood M, Foster C. Face-to-face interventions for promoting physical activity. Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD010392. doi: 10.1002/14651858.CD010392.pub2.

  PMID: 24085592 BACKGROUND

• Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.

  PMID: 15674903 BACKGROUND

• Aznar S, Webster T. Actividad física y salud en la infancia y la adolescencia: Guía para todas las personas [Internet]. 2006. Available from: http://www.msssi.gob.es/ciudadanos/proteccionSalud/adultos/actiFisica/docs/ActividadFisicaSaludEspanol.pdf

  BACKGROUND

• Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based guidelines. ACCP/AACVPR Pulmonary Rehabilitation Guidelines Panel. American College of Chest Physicians. American Association of Cardiovascular and Pulmonary Rehabilitation. Chest. 1997 Nov 5;112(5):1363-96. No abstract available.

  PMID: 9367481 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Médicas FDEC, Del R, Hdl C, Carol A, Rojas J. Departamento de Postgrado ANTE EL EJERCICIO FISICO AEROBICO Y ANAEROBICO

  BACKGROUND

• Gomez LF, Duperly J, Lucumi DI, Gamez R, Venegas AS. [Physical activity levels in adults living in Bogota (Colombia): prevalence and associated factors]. Gac Sanit. 2005 May-Jun;19(3):206-13. doi: 10.1157/13075953. Spanish.

  PMID: 15960953 BACKGROUND

• Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. doi: 10.7326/0003-4819-137-3-200208060-00015.

  PMID: 12160371 BACKGROUND

• Ilarraza-Lomeli H. [Cardiopulmonary exercise testing]. Arch Cardiol Mex. 2012 Apr-Jun;82(2):160-9. Spanish.

  PMID: 22735657 BACKGROUND

• Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.

  PMID: 9817683 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Juan Ávila, PT

  Clínica de Occidente S.A

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: January 24, 2022
• Study Start: May 10, 2019
• Primary Completion: July 25, 2019
• Study Completion: December 25, 2019
• Last Updated: January 24, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)