- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05382117
Cardiac Rhythm and Affecting Factors in Patients Hospitalized in the Physical Therapy and Rehabilitation Clinic
Study Overview
Status
Conditions
Detailed Description
Neuromusculoskeletal disorders include a variety of fairly common pathologies that can have a major impact on a person's health. Today, neuromusculoskeletal diseases are the main causes of occupational diseases and chronic physical disability leading to high health care costs globally. Exercise therapy is seen as an important part of the treatment of many neuromusculoskeletal diseases.
Patients hospitalized in the physical therapy and rehabilitation clinic are generally elderly people with chronic neuromusculoskeletal system disorders. While the presence of ventricular premature beat is detected in more than 50% of healthy adults in 24 hour rhythm holter examination, this rate rises above 90% in the elderly.Although many studies have noted that regular exercise and high cardiovascular fitness reduce the risk of cardiovascular arrhythmias, exercise may paradoxically increase the risk of sudden cardiac death in those with preexisting cardiac abnormalities.
There are no studies evaluating the changes in heart rhythms during hospitalization of patients hospitalized for treatment in physical therapy and rehabilitation clinics where exercise therapy is frequently applied.In our study, it is aimed to evaluate the cardiac rhythms of patients who receive inpatient treatment in the physical therapy and rehabilitation clinic with 24 hour rhythm holter follow up on the day of hospitalization and three weeks after hospitalization and to determine the factors that may affect this result if a significant change is observed between the two measurements.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey, 22030
- Trakya University Medical Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be over 18 years old
- To be evaluated for any neuromusculoskeletal system disease and decided to be treated as an inpatient in the physical therapy and rehabilitation clinic
- Having agreed to participate in the study
Exclusion Criteria:
- A change in medication that may affect cardiac rhythm in the last two weeks
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evalution of the cardiac arrhythmia
Time Frame: up to three weeks
|
24-hour cardiac rhythm recording by holter device
|
up to three weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Robinson JG, Bakris G, Torner J, Stone NJ, Wallace R. Is it time for a cardiovascular primary prevention trial in the elderly? Stroke. 2007 Feb;38(2):441-50. doi: 10.1161/01.STR.0000254602.58896.d2. Epub 2006 Dec 28.
- Ephrem G, Levine M, Friedmann P, Schweitzer P. The prognostic significance of frequency and morphology of premature ventricular complexes during ambulatory holter monitoring. Ann Noninvasive Electrocardiol. 2013 Mar;18(2):118-25. doi: 10.1111/anec.12010. Epub 2012 Nov 22.
- Winkens RA, Hoppener PF, Kragten JA, Verburg MP, Crebolder HF. Are premature ventricular contractions always harmless? Eur J Gen Pract. 2014 Jun;20(2):134-8. doi: 10.3109/13814788.2013.859243. Epub 2013 Nov 28.
- Frishman WH, Heiman M, Karpenos A, Ooi WL, Mitzner A, Goldkorn R, Greenberg S. Twenty-four-hour ambulatory electrocardiography in elderly subjects: prevalence of various arrhythmias and prognostic implications (report from the Bronx Longitudinal Aging Study). Am Heart J. 1996 Aug;132(2 Pt 1):297-302. doi: 10.1016/s0002-8703(96)90425-1.
- Morris JN, Heady JA, Raffle PA, Roberts CG, Parks JW. Coronary heart-disease and physical activity of work. Lancet. 1953 Nov 28;262(6796):1111-20; concl. doi: 10.1016/s0140-6736(53)91495-0. No abstract available.
- Harmon KG, Drezner JA, Wilson MG, Sharma S. Incidence of sudden cardiac death in athletes: a state-of-the-art review. Heart. 2014 Aug;100(16):1227-34. doi: 10.1136/heartjnl-2014-093872.rep.
- Adrian D. Elliott , Dominik Linz, Christian V. Verdicchio, Prashanthan Sanders Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital and the South Australian Health & Medical Research Institute, 7 Adelaide, SA, Australia Heart, Lung and Circulation (2018) xx, 1--8 1443-9506/04
- Lewczuk J, Piszko P, Jagas J, Porada A, Sobkowicz-Wozniak B, Wrabec K. [Effect of acute exercise on cardiac arrhythmias in the course of chronic obstructive pulmonary disease]. Pneumonol Alergol Pol. 1994;62(9-10):496-500. Polish.
- Manolis AS, Manolis AA. Exercise and Arrhythmias: A Double-Edged Sword. Pacing Clin Electrophysiol. 2016 Jul;39(7):748-62. doi: 10.1111/pace.12879. Epub 2016 May 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurumusculoskeletal Disorders
-
Indivior Inc.CompletedOpioid-related DisordersUnited States
-
University Hospital, CaenUnknownAlcohol Disorders
-
Rennes University HospitalCompletedAtypical Cognitive DisordersFrance
-
University of NebraskaCompletedSubstance-related Disorders | Alcohol-related DisordersUnited States
-
Dartmouth-Hitchcock Medical CenterCompletedOpioid Related DisordersUnited States
-
New York State Psychiatric InstituteSchering-PloughCompleted
-
Chengdu University of Traditional Chinese MedicineRecruiting
-
West Virginia UniversityNational Institute on Drug Abuse (NIDA); MedtronicActive, not recruitingOpioid-Related DisordersUnited States
-
University of WashingtonNational Institute on Drug Abuse (NIDA); emocha Mobile Health, Inc.CompletedOpioid-Related DisordersUnited States
-
Potomac Health FoundationsCompletedOpioid-Related DisordersUnited States