Neurumusculoskeletal DisordersNCT05382117
Cardiac Rhythm and Affecting Factors in Patients Hospitalized in the Physical Therapy and Rehabilitation Clinic
An observational study of Neurumusculoskeletal Disorders, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
In our study, it is aimed to evaluate the cardiac rhythms of patients who are decided to receive inpatient treatment in the physical therapy and rehabilitation clinic due to any neuromusculoskeletal diseases with 24 hour rhythm holter follow up on the day of hospitalization and three weeks after hospitalization and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurumusculoskeletal Disorders
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2021to 28 Dec 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in Trakya University Hospital Physiotherapy and Rehabilitation Clinic
Who may be able to join
- 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
Who cannot join
- A change in medication that may affect cardiac rhythm in the last two weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Medical Faculty
Edirne, 22030
About this study
In our study, it is aimed to evaluate the cardiac rhythms of patients who are decided to receive inpatient treatment in the physical therapy and rehabilitation clinic due to any neuromusculoskeletal diseases 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.The present results will guide the determination of the exercise duration, intensity, type and severity of the exercises to be created within the scope of the treatment programs of the patients and will lead to similar studies.
Read the 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.
- Conditions
- Neurumusculoskeletal Disorders
- Keywords
- neuromusculoskeletal, cardiovascular fitness,rhythm
What is being measured
The primary outcome is the main question the study is designed to answer.
Evalution of the cardiac arrhythmia
24-hour cardiac rhythm recording by holter device
Measured: up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start29 Dec 2021
- Primary completion28 Dec 2022 (estimated)
- Study completion28 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neurumusculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Ozdemir, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382117
- Sponsor's protocol ID
- 2021/161
- Status last verified
- Jun 2022
- First submitted
- 16 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17194877Ephrem 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.
PubMed 23530481Winkens 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.
PubMed 24286118Frishman 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.
PubMed 8701890Morris 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.
PubMed 13110075Harmon 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.
PubMed 25049314Adrian 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.
PubMed 7866322Manolis 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.
PubMed 27120033
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rhythm and Affecting Factors in Patients Hospitalized in the Physical Therapy and Rehabilitation Clinic
- ClinicalTrials.gov ID
- NCT05382117
- Acronym / sponsor ID
- 2021/161
- Conditions
- Neurumusculoskeletal Disorders
- Keywords
- neuromusculoskeletal, cardiovascular fitness,rhythm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 28 Dec 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our study, it is aimed to evaluate the cardiac rhythms of patients who are decided to receive inpatient treatment in the physical therapy and rehabilitation clinic due to any neuromusculoskeletal diseases 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.The present results will guide the determination of the exercise duration, intensity, type and severity of the exercises to be created within the scope of the treatment programs of the patients and will lead to similar studies.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Trakya University Hospital Physiotherapy and Rehabilitation Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- A change in medication that may affect cardiac rhythm in the last two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evalution of the cardiac arrhythmia
Time frame: up to three weeks
24-hour cardiac rhythm recording by holter device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Background: PubMed 17194877Robinson 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.
- Background: PubMed 23530481Ephrem 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.
- Background: PubMed 24286118Winkens 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.
- Background: PubMed 8701890Frishman 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.
- Background: PubMed 13110075Morris 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.
- Background: PubMed 25049314Harmon 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.
- BackgroundAdrian 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
- Background: PubMed 7866322Lewczuk 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.
- Background: PubMed 27120033Manolis 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurumusculoskeletal Disorders, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evalution of the cardiac arrhythmia (time frame: up to three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382117, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.