Heart Failure With Reduced Ejection FractionICDNCT04803968
The Effect of Combined Upper and Lower Extremity Endurance Training in Patients With ICD
A study testing bicycle ergometer and arm ergometer exercise and bicycle ergometer exercise in people with Heart Failure With Reduced Ejection Fraction, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to examine whether the arm endurance exercise training is effective in addition to the lower cycling training program in order to alleviate the negative functional results in heart failure patients with ICD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- bicycle ergometer and arm ergometer exercise and bicycle ergometer exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of heart failure in the New York Heart Association (NYHA) class II-III, who have had at least 3 months past ICD implantation, and who did not have any complications at the last pacemaker control,
- Ejection fraction (EF) value ≤45%,
- The medicines used have not been changed for at least 3 months,
- Volunteering to participate in the research, being able to attend a 1-hour rehabilitation program every day of the week,
- To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
- Not having any orthopedic problems that may prevent him from exercising with his bicycle and arm ergometer,
- CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECHO without any obstacle to exercise within the framework of TKD cardiology guidelines (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT…).
Who cannot join
- Those with a history of shoulder injury (severe pain around the shoulder and inability to move, severe swelling around the shoulder, shoulder dislocation)
- Those with a history of shoulder surgery,
- Sequelae of a cerebrovascular accident with mastectomy or arm involvement on the affected side,
- Having decompensated heart failure,
- Having an obstacle to exercise within the framework of TSC (Turkish Society of Cardiology) cardiology guidelines in CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECO (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT ...)
- Having a history of ICD shock in the last 6 months,
Show all 9Show fewer
- Having an active treated malignancy or a collagen tissue disease receiving systemic steroids
- Being unable to cooperate or adapt to exercise due to cerebrovascular disease or other reasons,
- Having a chronic kidney disease undergoing dialysis where the volume load is not stable.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit University
Çorum, 19030
EBRU ÇALIK KÜTÜKCÜ
YUSUF KARAVELİOĞLU
About this study
Official title: The Effect of Upper Extremity Endurance Training Applied in Addition to Lower Extremity Endurance Training on Functional Capacity and Pacemaker Functions in Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD)
It was aimed to examine whether the arm endurance exercise training is effective in addition to the lower cycling training program in order to alleviate the negative functional results in heart failure patients with ICD.
Read the detailed description
Pacemaker (permanent battery) is implanted in patients for many reasons. For reasons such as symptomatic bradycardia and AV block, a pacemaker with modes such as VVR and DDDR designed for pacing only when the pulse decreases can be implanted. At the same time, pacemakers can be implanted in VR-ICD, DR-ICD modes, which have the ability to recognize fatal rhythm problems such as Ventricular tachycardia (VT) / Ventricular Fibrillation (VF) and perform intracardiac defibrillation (ICD).
Pacemakers are positioned by opening a pocket under the patient's left pectoral muscle.Cables coming out of the battery (leads) are placed in the right ventricle, right atrium or coronary sinuses via active or passive fixation through the left subclavian vein. In the early period after pacemaker implantation, patients are warned to avoid movements that force the extremity on that side so that the leads and battery are affected by extremity movements and their positions and functions are not impaired.
Many pacemaker patients prolong this period too much (> 3 months), causing them to develop left extremity muscle-joint dysfunction. This situation can also affect the functional capacity of the patients.ICD pacemakers are larger in size than conventional pacemakers due to their functions, so they are placed in a larger pocket in the pectoral area.These patients are warned more strictly about coercive movements.
The aim of this study is to investigate the effect of arm ergometer endurance training on functional capacity and upper extremity function in heart failure patients with ICD included in cardiac rehabilitation program, and to examine the effect on battery and leads as safety parameters.
- Being tested
- bicycle ergometer and arm ergometer exercise, bicycle ergometer exercise
- Keywords
- Implantable cardiac defibrillator, Upper extremity endurance training, peak Oxygen consumption, upper extremity functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicycle ergometer and arm ergometer exerciseOther
After the bicycle ergometer training is completed, there will be a 15-minute break for blood pressure measurement of the patients.
Then the combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group.
For this, the patient will sit upright in front of the height-adjustable arm ergometer stand (Lode Angio Arm Ergometer with Automat) with the fulcrum of the handle at shoulder height.
The arm endurance training group will work for a total of 20 minutes, at 60% of the peak workload and at 50 rpm.
bicycle ergometer exerciseOther
All patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training (Lode Corival Cpet Ergoline type: 960900 serial number: 20160094, Netherlands). The exercise protocol for the lower extremities will consist of a total of 40 minutes, including an 8-minute warm-up phase and an 8-minute cool-down phase. Exercise intensity, on the other hand, will be arranged as recommended in the European Society of Cardiology (ESC) 2020 guideline for chronic heart failure patients, at a workload corresponding to 70-80% of peak oxygen consumption (VO2peak), with a turnover rate of 60 cycles / min.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | After the evaluations are completed, the participants will be randomly divided into two groups using a computer-assisted randomization program.
The cardiac rehabilitation program will be a total of 30 sessions, 5 days a week x 6 weeks. All patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training Receives: Other: bicycle ergometer exercise |
| intervention group | Experimental | The combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group. Receives: Other: bicycle ergometer and arm ergometer exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory functional capacity
Cardiopulmonary exercise test (CPET):
It evaluates the aerobic capacity before the rehabilitation program and evaluates the responses to exercise and is used as the gold standard. A ramp bicycle ergometer test protocol will be applied for CPET. Parameters such as exercise duration, Watt, VO2, VCO2, blood pressure, heart rate, dyspnea, leg fatigue, general fatigue and effort perception according to the modified Borg scale, SaO2 will be saved at rest, AT (at anaerobic threshold), at peak level and at the end of the test in the recovery phase.
At the end of the test, the reason for completing the test will be recorded. As one of the criteria for completing the test, attention will be paid to having the RER value of 1.05 and above. Results will be printed with 9 panel charts. (Gas analyzer; CORTEX METALYZER 3B Germany, bicycle; Lode Corival-cpet ERGOMETER, 12 channel ECG test system; Custo Cardio 200 BT system, Netherlands)
Measured: Through study completion, an average of 1 year
Arm ergometer endurance capacity
The Lode Angio Arm Ergometer (with automatic stand, type: 917900 serial number:20160739, The Netherlands) device will be used for the arm ergometer test. It will start rotating the arm ergometer at 0 Watt (W) workload and at a speed of 60-75 rpm and will progress with a 10 W workload increase every 2 minutes. Modified Borg scores will be recorded for the patient's perception of arm fatigue and dyspnea before each workload increase. When the patient reaches one of the test termination criteria, the test will be terminated and the last achieved workload will be recorded as W and due to termination of the test.
Measured: Through study completion, an average of 1 year
6 minute pegboard and ring test
Participants will sit in front of a board with two top pegs, two bottom pegs and 10 rings on top of it. The lower pegs will be placed at the participant's shoulder height, and the upper pegs will be placed in the hole 20 cm above the lower pegs. Within a 6-minute period, participants will be asked to move as many rings as possible from the lower pegs to the upper pegs.
Before and after each test, blood pressure, heart rate, SpO2 (Veron, VRN-502 pulse oximeter), dyspnea and arm fatigue detection (modified borg scale) will be recorded.
The test will be performed a second time after the first test is completed, after a 30-minute interval or after the relevant variables return to their initial values. If the patient wants to rest during the test, they will be allowed but the stopwatch will not be stopped. During the test, patients will be encouraged every minute. The result of the test is the total number of rings carried.
Measured: Through study completion, an average of 1 year
Handgrip
The measurements will be made in three repetitions for the right and left sides, with the shoulder in the sitting position, the elbow in 90 ° flexion, and the forearm in neutral position (Smedley Digital Hand Dynamometer, Model: 12-0286, Baseline, Fabrication Enterprises Inc (FEI), USA). For statistical analysis, the best values of the right and left sides and the arithmetic means of both sides will be recorded.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Quick DASH
It is an abbreviation of the 30-item Quick-DASH questionnaire used to evaluate one or more musculoskeletal physical functions and symptoms of the upper extremity. It consists of 11 items. The results of the questionnaire will be evaluated on a 100 point scale and higher scores will indicate the presence of more disability.
Measured: Through study completion, an average of 1 year
The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ consists of 21 items and measures three important dimensions (physical, socioeconomic and psychological) of quality of life in patients with heart failure. It is scored with a 6-point Likert scale graded as 0 (no effect / not valid, best score) -5 (severe impact, worst score) within an average of 5 minutes. It can be applied by itself or by an interviewer.
The total score of the scale for 21 questions ranges from 0 to 105, and higher scores indicate a lower quality of life.
The patients' quality of life will be evaluated with the "Minnesota Heart Failure Life Questionnaire", which measures the quality of life specific to heart failure. The Turkish validity and reliability of the questionnaire has been done.
Measured: Through study completion, an average of 1 year
General Practice Physical Activity Questionnaire (GPPAQ)
The "General Practice Physical Activity Questionnaire" (GPPAQ), which was developed to evaluate the physical activity level of adults in primary care, consists of seven questions under three main headings. It is a scale that takes about 30-60 seconds to fill. In the first part of the scale, a question is asked about the mobility of the person in the workplace, while the second part is asked about the activities performed in the last seven days and how many hours per week. In the last part, there is a question that evaluates the normal walking speed of the person.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Ayşe Akdal, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803968
- Sponsor's protocol ID
- 322
- Acronym
- ICD
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Extremity Endurance Training Applied in Addition to Lower Extremity Endurance Training on Functional Capacity and Pacemaker Functions in Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD)
- ClinicalTrials.gov ID
- NCT04803968
- Acronym / sponsor ID
- ICD / 322
- Keywords
- Implantable cardiac defibrillator, Upper extremity endurance training, peak Oxygen consumption, upper extremity functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Mar 2021 (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.
It was aimed to examine whether the arm endurance exercise training is effective in addition to the lower cycling training program in order to alleviate the negative functional results in heart failure patients with ICD.
Detailed description
Pacemaker (permanent battery) is implanted in patients for many reasons. For reasons such as symptomatic bradycardia and AV block, a pacemaker with modes such as VVR and DDDR designed for pacing only when the pulse decreases can be implanted. At the same time, pacemakers can be implanted in VR-ICD, DR-ICD modes, which have the ability to recognize fatal rhythm problems such as Ventricular tachycardia (VT) / Ventricular Fibrillation (VF) and perform intracardiac defibrillation (ICD).
Pacemakers are positioned by opening a pocket under the patient's left pectoral muscle.Cables coming out of the battery (leads) are placed in the right ventricle, right atrium or coronary sinuses via active or passive fixation through the left subclavian vein. In the early period after pacemaker implantation, patients are warned to avoid movements that force the extremity on that side so that the leads and battery are affected by extremity movements and their positions and functions are not impaired.
Many pacemaker patients prolong this period too much (> 3 months), causing them to develop left extremity muscle-joint dysfunction. This situation can also affect the functional capacity of the patients.ICD pacemakers are larger in size than conventional pacemakers due to their functions, so they are placed in a larger pocket in the pectoral area.These patients are warned more strictly about coercive movements.
The aim of this study is to investigate the effect of arm ergometer endurance training on functional capacity and upper extremity function in heart failure patients with ICD included in cardiac rehabilitation program, and to examine the effect on battery and leads as safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: bicycle ergometer exerciseAfter the evaluations are completed, the participants will be randomly divided into two groups using a computer-assisted randomization program. The cardiac rehabilitation program will be a total of 30 sessions, 5 days a week x 6 weeks. All patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training |
| intervention group | Experimental | Other: bicycle ergometer and arm ergometer exerciseThe combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of heart failure in the New York Heart Association (NYHA) class II-III, who have had at least 3 months past ICD implantation, and who did not have any complications at the last pacemaker control,
- Ejection fraction (EF) value ≤45%,
- The medicines used have not been changed for at least 3 months,
- Volunteering to participate in the research, being able to attend a 1-hour rehabilitation program every day of the week,
- To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
Key exclusion criteria (9 listed)
- Those with a history of shoulder injury (severe pain around the shoulder and inability to move, severe swelling around the shoulder, shoulder dislocation)
- Those with a history of shoulder surgery,
- Sequelae of a cerebrovascular accident with mastectomy or arm involvement on the affected side,
- Having decompensated heart failure,
- Having an obstacle to exercise within the framework of TSC (Turkish Society of Cardiology) cardiology guidelines in CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECO (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bicycle ergometer and arm ergometer exerciseAfter the bicycle ergometer training is completed, there will be a 15-minute break for blood pressure measurement of the patients. Then the combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group. For this, the patient will sit upright in front of the height-adjustable arm ergometer stand (Lode Angio Arm Ergometer with Automat) with the fulcrum of the handle at shoulder height. The arm endurance training group will work for a total of 20 minutes, at 60% of the peak workload and at 50 rpm. | Other | intervention group |
| bicycle ergometer exerciseAll patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training (Lode Corival Cpet Ergoline type: 960900 serial number: 20160094, Netherlands). The exercise protocol for the lower extremities will consist of a total of 40 minutes, including an 8-minute warm-up phase and an 8-minute cool-down phase. Exercise intensity, on the other hand, will be arranged as recommended in the European Society of Cardiology (ESC) 2020 guideline for chronic heart failure patients, at a workload corresponding to 70-80% of peak oxygen consumption (VO2peak), with a turnover rate of 60 cycles / min. | Other | control group |
Primary outcome
Cardiorespiratory functional capacity
Time frame: Through study completion, an average of 1 year
Cardiopulmonary exercise test (CPET): It evaluates the aerobic capacity before the rehabilitation program and evaluates the responses to exercise and is used as the gold standard. A ramp bicycle ergometer test protocol will be applied for CPET. Parameters such as exercise duration, Watt, VO2, VCO2, blood pressure, heart rate, dyspnea, leg fatigue, general fatigue and effort perception according to the modified Borg scale, SaO2 will be saved at rest, AT (at anaerobic threshold), at peak level and at the end of the test in the recovery phase. At the end of the test, the reason for completing the test will be recorded. As one of the criteria for completing the test, attention will be paid to having the RER value of 1.05 and above. Results will be printed with 9 panel charts. (Gas analyzer; CORTEX METALYZER 3B Germany, bicycle; Lode Corival-cpet ERGOMETER, 12 channel ECG test system; Custo Cardio 200 BT system, Netherlands)
Arm ergometer endurance capacity
Time frame: Through study completion, an average of 1 year
The Lode Angio Arm Ergometer (with automatic stand, type: 917900 serial number:20160739, The Netherlands) device will be used for the arm ergometer test. It will start rotating the arm ergometer at 0 Watt (W) workload and at a speed of 60-75 rpm and will progress with a 10 W workload increase every 2 minutes. Modified Borg scores will be recorded for the patient's perception of arm fatigue and dyspnea before each workload increase. When the patient reaches one of the test termination criteria, the test will be terminated and the last achieved workload will be recorded as W and due to termination of the test.
6 minute pegboard and ring test
Time frame: Through study completion, an average of 1 year
Participants will sit in front of a board with two top pegs, two bottom pegs and 10 rings on top of it. The lower pegs will be placed at the participant's shoulder height, and the upper pegs will be placed in the hole 20 cm above the lower pegs. Within a 6-minute period, participants will be asked to move as many rings as possible from the lower pegs to the upper pegs. Before and after each test, blood pressure, heart rate, SpO2 (Veron, VRN-502 pulse oximeter), dyspnea and arm fatigue detection (modified borg scale) will be recorded. The test will be performed a second time after the first test is completed, after a 30-minute interval or after the relevant variables return to their initial values. If the patient wants to rest during the test, they will be allowed but the stopwatch will not be stopped. During the test, patients will be encouraged every minute. The result of the test is the total number of rings carried.
Handgrip
Time frame: Through study completion, an average of 1 year
The measurements will be made in three repetitions for the right and left sides, with the shoulder in the sitting position, the elbow in 90 ° flexion, and the forearm in neutral position (Smedley Digital Hand Dynamometer, Model: 12-0286, Baseline, Fabrication Enterprises Inc (FEI), USA). For statistical analysis, the best values of the right and left sides and the arithmetic means of both sides will be recorded.
3 secondary outcomes
Quick DASH
Time frame: Through study completion, an average of 1 year
The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: Through study completion, an average of 1 year
General Practice Physical Activity Questionnaire (GPPAQ)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bicycle ergometer and arm ergometer exercise and bicycle ergometer exercise in people with Heart Failure With Reduced Ejection Fraction, run by Hitit 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 7 inclusion and 9 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 1 Apr 2021. 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?
Contact AYŞE AKDAL (+905457198755, ayseakdal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory functional capacity (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021.