High Intensity Interval TrainingNCT06754475
Effects of Upper Extremity Low Volume HIIT in Heart Failure
A study testing Low-volume, high-intensity interval training and Standart medical treatment in people with High Intensity Interval Training and Heart Failure, run by Tarsus University at 2 sites in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effects of upper extremity low-volume high-intensity interval training (LV-HIIT) on physical and cognitive function in patients with heart failure with preserved ejection fraction(HFpEF).The research was planned as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Intensity Interval Training, Heart Failure, Exercises
- What is being tested?
- Low-volume, high-intensity interval training and Standart medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Clinical condition stable for ≥4 weeks.
- New York Heart Association functional classification I-II to III
- Over 18 years old
Who cannot join
- History of CABG surgery
- Unstable angina pectoris
- Severe arrhythmia
- Acute pericarditis, endocarditis, myocarditis
- Severe left ventricular failure (EF <40%)
- Acute pulmonary embolism
Show all 15Show fewer
- History of syncope
- Dissecting aneurysm
- Thrombophlebitis
- Orthopedic disorders that may interfere with exercise
- Uncontrolled hypertension, severe pulmonary arterial hypertension
- Moderate-severe valve disease
- Decompensated Congestive Heart Failure
- Electrolyte abnormalities
- Hypertrophic Cardiomyopathy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Tarsus University, TARSUS, Mersin
Mersin, Mersin
Nurel Ertürk, 05056637544, nrlbllr@gmail.com
- Recruiting
Nurel Ertürk, TARSUS, Mersin
Yenişehir, Mersin
Nurel Ertürk, 05056637544
About this study
Official title: The Effect of Upper Extremity Low-Volume High-Intensity Interval Training on Physical and Cognitive Functions in Heart Failure Patients
This study was planned to investigate the effects of upper extremity low-volume high-intensity interval training (LV-HIIT) on physical and cognitive function in patients with heart failure with preserved ejection fraction(HFpEF).The research was planned as a randomized controlled trial. Patients with clinically stable HFpEF at cardiology clinic will be included in the study. These cases will be randomly divided into two groups: intervention group and control grup. After 8 weeks intervention physical functions before and after treatment; functional exercise capacity, arm exercise capacities , peripheral muscle strength , fatigue cognitive functions; anxiety and depression and fear of movement will be evaluated.
Read the detailed description
Patients in the DV-HIIT group will receive training consisting of 4 minutes of warm-up and cool-down at 50% Wmax on an arm ergometer, 1 minute of training at 85-95% Wmax work intensity, followed by 6 interval training periods including 1 minute of active recovery periods at 50-70% Wmax, 2 days/week, totaling 8 weeks of training. The control group will be followed with standard medical treatment.
- Conditions
- High Intensity Interval Training, Heart Failure, Exercises
- Being tested
- Low-volume, high-intensity interval training, Standart medical treatment
- Keywords
- high intensity interval training, upper extremity, exercises capacity
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-volume, high-intensity interval trainingOther
Low-volume, high-intensity interval training with an arm ergometer will be given two days a week for a total of eight weeks.
Standart medical treatmentDrug
Standart medical teatment
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | İntervention Group: LV-HIIT Receives: Other: Low-volume, high-intensity interval training |
| Control group | Other | Control group Receives: Drug: Standart medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal arm exercises capacity
maximal arm exercises capacity will measurement with arm ergometer test.
Measured: At baseline and after 8 week
Functional capacity
Functional capacity will be assessed with the six-minute walk test (6MWT).
Measured: At baseline and after 8 week
Upper extremity muscle strength
Upper extremity muscle strength will be evaluated with a digital dynamometer and hand grip strength will be evaluated with a jamar.
Measured: At baseline and after 8 week
reaction time
The auditory and visual reaction times of the individuals will be determined. The instrument used during the test can give three stimuli and consists of two parts, In measuring the reaction times, care will be taken to ensure that the measurement area is a noiseless and light-receiving environment. Individuals will be told the technique of the test and will be asked to make 1 attempt against sound and light stimulation. After the trial, 3 measurements will be taken and the results will be recorded in milliseconds
Measured: At baseline and after 8 week
cognitive function
Mini mental Questionaire will use. Min 24 point is the cut of for this test
Measured: At baseline and after 8 week
Postural sway
The postural oscillations of the patients will be evaluated with the body oscillation device, which measures the oscillation in two axes. In this test, the participant will be asked to stand in the upright position with a distance of 10 cm between the two feet and to maintain your upright position for 30 seconds. The participant will be measured twice with the eyes open and closed. With these measurements, the mediolateral and anteroposterior oscillation distances of the patients will be measured and recorded on the computer
Measured: At baseline and after 8 week
heart rate variablity
Measured: At baseline and after 8 week
Secondary outcomes (3)
hand steadness
The auditory and visual reaction times of the individuals will be determined. The instrument used during the test can give three stimuli and consists of two parts, In measuring the reaction times, care will be taken to ensure that the measurement area is a noiseless and light-receiving environment. Individuals will be told the technique of the test and will be asked to make 1 attempt against sound and light stimulation. After the trial, 3 measurements will be taken and the results will be recorded in milliseconds.
Measured: At baseline and after 8 week
Anxiety and depresion
Hospital anxiety and depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). It is worth noting that items referring to depression symptoms that describe somatic aspects of depression (e.g. insomnia and weight loss) are not included in the scale.
Measured: At baseline and after 8 week
activities of daily living
Nottingham Health Profile (NHP) will used. The questionnaire is divided into two parts. The first parts comprises 38 questions in six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation.The second part of the NHP is made up of seven statements about areas of life that are commonly affected by health: paid employment, jobs around the house, social life, personal relationships, sex life, hobbies and interests, and holidays. Scores on the NHP can range from 0 i.e. no distress to 100 i.e severe distress.
Measured: At baseline and after 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Interval TrainingStudies 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
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurel Ertürk, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754475
- Sponsor's protocol ID
- 2024/17
- Status last verified
- Nov 2024
- First submitted
- 23 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD collected throughout the trial, only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Extremity Low-Volume High-Intensity Interval Training on Physical and Cognitive Functions in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06754475
- Acronym / sponsor ID
- 2024/17
- Conditions
- High Intensity Interval Training, Heart Failure, Exercises
- Keywords
- high intensity interval training, upper extremity, exercises capacity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Dec 2024 (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.
This study was planned to investigate the effects of upper extremity low-volume high-intensity interval training (LV-HIIT) on physical and cognitive function in patients with heart failure with preserved ejection fraction(HFpEF).The research was planned as a randomized controlled trial. Patients with clinically stable HFpEF at cardiology clinic will be included in the study. These cases will be randomly divided into two groups: intervention group and control grup. After 8 weeks intervention physical functions before and after treatment; functional exercise capacity, arm exercise capacities , peripheral muscle strength , fatigue cognitive functions; anxiety and depression and fear of movement will be evaluated.
Detailed description
Patients in the DV-HIIT group will receive training consisting of 4 minutes of warm-up and cool-down at 50% Wmax on an arm ergometer, 1 minute of training at 85-95% Wmax work intensity, followed by 6 interval training periods including 1 minute of active recovery periods at 50-70% Wmax, 2 days/week, totaling 8 weeks of training. The control group will be followed with standard medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Low-volume, high-intensity interval trainingİntervention Group: LV-HIIT |
| Control group | Other | Drug: Standart medical treatmentControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical condition stable for ≥4 weeks.
- New York Heart Association functional classification I-II to III
- Over 18 years old
Key exclusion criteria (15 listed)
- History of CABG surgery
- Unstable angina pectoris
- Severe arrhythmia
- Acute pericarditis, endocarditis, myocarditis
- Severe left ventricular failure (EF <40%)
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 |
|---|---|---|
| Low-volume, high-intensity interval trainingLow-volume, high-intensity interval training with an arm ergometer will be given two days a week for a total of eight weeks. | Other | Patients |
| Standart medical treatmentStandart medical teatment | Drug | Control group |
Primary outcome
maximal arm exercises capacity
Time frame: At baseline and after 8 week
maximal arm exercises capacity will measurement with arm ergometer test.
Functional capacity
Time frame: At baseline and after 8 week
Functional capacity will be assessed with the six-minute walk test (6MWT).
Upper extremity muscle strength
Time frame: At baseline and after 8 week
Upper extremity muscle strength will be evaluated with a digital dynamometer and hand grip strength will be evaluated with a jamar.
reaction time
Time frame: At baseline and after 8 week
The auditory and visual reaction times of the individuals will be determined. The instrument used during the test can give three stimuli and consists of two parts, In measuring the reaction times, care will be taken to ensure that the measurement area is a noiseless and light-receiving environment. Individuals will be told the technique of the test and will be asked to make 1 attempt against sound and light stimulation. After the trial, 3 measurements will be taken and the results will be recorded in milliseconds
cognitive function
Time frame: At baseline and after 8 week
Mini mental Questionaire will use. Min 24 point is the cut of for this test
Postural sway
Time frame: At baseline and after 8 week
The postural oscillations of the patients will be evaluated with the body oscillation device, which measures the oscillation in two axes. In this test, the participant will be asked to stand in the upright position with a distance of 10 cm between the two feet and to maintain your upright position for 30 seconds. The participant will be measured twice with the eyes open and closed. With these measurements, the mediolateral and anteroposterior oscillation distances of the patients will be measured and recorded on the computer
heart rate variablity
Time frame: At baseline and after 8 week
3 secondary outcomes
hand steadness
Time frame: At baseline and after 8 week
Anxiety and depresion
Time frame: At baseline and after 8 week
activities of daily living
Time frame: At baseline and after 8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No. All IPD collected throughout the trial, only IPD used in the results publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-volume, high-intensity interval training and Standart medical treatment in people with High Intensity Interval Training and Heart Failure, run by Tarsus University at 2 sites 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 15 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurel ERTÜRK (+905056637544, nrlbllr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal arm exercises capacity (time frame: At baseline and after 8 week). The study lists 7 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 3 Jan 2025.