NCT05890443

Brief Summary

Abstract Purpose: This study aimed to determine the effect of mobile application-based exercise programs on the quality of life and dyspnea of patients with chronic obstructive pulmonary disease. This study was designed experimentally with a randomized control group. Methods: A total of 76 COPD patients were included in the study. Individuals aged 40 and over with COPD were included in the study, while individuals with communication, mental, neurological and cognitive problems and unable to exercise were excluded from the study. Among those who met the inclusion criteria, those who had a smart-phone were assigned to the experimental group, while those who did not have a smart-phone were assigned to the control group. Self-management training was given to all individuals in both the control and experimental groups. After the training, the Saint George Respiratory Questionnaire (SGRQ) and dyspnea tests were administered to both groups. After the rehabilitation exercise program developed for the patients in the experimental group was applied, the tests were repeated for all groups. Results: The mean age of the patients in the study was 65.5708± 9 in the control group, while the mean age of the experimental group was 67.61± 9.93. While the Borg dyspnea scale results of the experimental group were 6.45± 1.90 in the first test, the post-test measurements were 5.16± 1.65 (t = 7.66, p = 0.00). SGRQ pre-test and post-test total scores were 50.78± 16.39 and 41.99±15.04, respectively, in the experimental group (t=6.80 and p=0.08). Conclusion: Respiratory and muscle strengthening exercises applied with the support of the mobile application, positively affected the quality of life of patients with COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 8, 2023

Last Update Submit

May 26, 2023

Conditions

Keywords

DyspneaMobile ApplicationQuality Of Life,Tele-rehabilitationCOPD

Outcome Measures

Primary Outcomes (2)

  • Dyspnea

    Modified Medical Research Counsel (mMRC) and modified borg dyspnea scales were used to determine the effect of respiratory strengthening exercises. Modified borg dyspnea scale;This scale is used to measure the degree of difficulty in breathing. Individuals are asked to rate their shortness of breath between 0 and 10. 0 means that breathing does not cause any difficulty, and 10 points mean that shortness of breath is maximum. The mMRC (Modified Medical Research Council) Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea. mMrc scale in daily activities a short scale used to rate the effects of shortness of breath.There is a scoring table between 0 and 4 points. 0 represents shortness of breath only during exercise, while 4 points; indicates the most severe shortness of breath.

    10 weeks

  • Respiratory quality of life

    St. George's Respiratory Questionnaire (SGRQ);Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.SGRQ This questionnaire consists of three sections: symptom, activity, and effects of the disease. The symptom section includes dyspnea, cough, sputum, and respiratory problems. The activity section investigates physical activities that are restricted due to shortness of breath. In the impact section, the effects of the disease on the daily life of the individual are assessed. The score range of the questionnaire is between 0 (perfect health) and 100 (most severe disease). A change of four units in the score is considered clinically significant. The total score is determined by adding up the scores of the three sections and dividing it by 100.

    10 weeks

Study Arms (2)

Group exercised via mobile application

EXPERIMENTAL

Individuals aged 40 and over with COPD were included in the study, while individuals with communication, mental, neurological and cognitive problems and unable to exercise were excluded from the study. Among those who met the inclusion criteria, those who had a smart-phone were assigned to the experimental group.

Behavioral: Exercise

The group not included in the exercises via the mobile application.

NO INTERVENTION

Individuals aged 40 and over with COPD were included in the study. The individuals with communication, mental, neurological and cognitive problems and unable to exercise were excluded from the study. Those who did not have a smart-phone were assigned to the control group.

Interventions

ExerciseBEHAVIORAL

Before starting the research, self-management training in rehabilitation was given to both groups. While the exercise practices were carried out in the experimental group, encouraging reminders were made by following the background web page created in the experimental group.

Also known as: self-management training
Group exercised via mobile application

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants;
  • Beıng 40 years or older,
  • Not to have partıcıpated ın the PR program durıng the last year,
  • Volunteering to partıcıpate ın the study,
  • Beıng dıagnosed wıth COPD,
  • Not having a condition that prevents you from exercising,
  • In addıtıon, for the experiment group, ıt ıs necessary to have a smart phone for hımself or a close person.

You may not qualify if:

  • Participants; Have a communication problem,
  • Having mental or neurological problems,
  • Having arthritis, advanced cardiovascular disease, and critical pulmonary hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ayten

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location

Seyhan Çıtlık SARITAŞ

Malatya, Battalgazi̇, 44210, Turkey (Türkiye)

Location

Related Publications (8)

  • Tsakanikas VD, Gatsios D, Dimopoulos D, Pardalis A, Pavlou M, Liston MB, Fotiadis DI. Evaluating the Performance of Balance Physiotherapy Exercises Using a Sensory Platform: The Basis for a Persuasive Balance Rehabilitation Virtual Coaching System. Front Digit Health. 2020 Nov 27;2:545885. doi: 10.3389/fdgth.2020.545885. eCollection 2020.

    PMID: 34713032BACKGROUND
  • Troosters T, Blondeel A, Janssens W, Demeyer H. The past, present and future of pulmonary rehabilitation. Respirology. 2019 Sep;24(9):830-837. doi: 10.1111/resp.13517. Epub 2019 Mar 13.

    PMID: 30868699BACKGROUND
  • Kosteli MC, Heneghan NR, Roskell C, Williams SE, Adab P, Dickens AP, Enocson A, Fitzmaurice DA, Jolly K, Jordan R, Greenfield S, Cumming J. Barriers and enablers of physical activity engagement for patients with COPD in primary care. Int J Chron Obstruct Pulmon Dis. 2017 Mar 28;12:1019-1031. doi: 10.2147/COPD.S119806. eCollection 2017.

  • Zhang F, Zhong Y, Qin Z, Li X, Wang W. Effect of muscle training on dyspnea in patients with chronic obstructive pulmonary disease: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Mar 5;100(9):e24930. doi: 10.1097/MD.0000000000024930.

  • Shen L, Zhang Y, Su Y, Weng D, Zhang F, Wu Q, Chen T, Li Q, Zhou Y, Hu Y, Jiang X, Jin X, Zhang A, Li H. New pulmonary rehabilitation exercise for pulmonary fibrosis to improve the pulmonary function and quality of life of patients with idiopathic pulmonary fibrosis: a randomized control trial. Ann Palliat Med. 2021 Jul;10(7):7289-7297. doi: 10.21037/apm-21-71.

  • Stamenova V, Liang K, Yang R, Engel K, van Lieshout F, Lalingo E, Cheung A, Erwood A, Radina M, Greenwald A, Agarwal P, Sidhu A, Bhatia RS, Shaw J, Shafai R, Bhattacharyya O. Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 30;22(7):e18598. doi: 10.2196/18598.

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  • Aboumatar H, Naqibuddin M, Chung S, Chaudhry H, Kim SW, Saunders J, Bone L, Gurses AP, Knowlton A, Pronovost P, Putcha N, Rand C, Roter D, Sylvester C, Thompson C, Wolff JL, Hibbard J, Wise RA. Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2019 Oct 8;322(14):1371-1380. doi: 10.1001/jama.2019.11982.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seyhan ÇITLIK SARITAŞ

    undefined [undefined:seyhancitlik@hotmail.com]

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Experimental and control groups were evaluated separately. There was no need for blinding.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A Randomized Experimental Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd,Rn,lecturer

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 6, 2023

Study Start

October 1, 2019

Primary Completion

December 20, 2019

Study Completion

June 15, 2021

Last Updated

June 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations