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RecruitingNCT06754475Updated Jan 3, 2025

Effects of Upper Extremity Low Volume HIIT in Heart Failure

An interventional study of Low-volume, high-intensity interval training and Standart medical treatment in High Intensity Interval Training, Heart Failure and Exercises, sponsored by Tarsus University. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.

Sponsored by Tarsus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • High Intensity Interval Training
  • Heart Failure
  • Exercises

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Keywords

  • high intensity interval training
  • upper extremity
  • exercises capacity
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Tarsus University is the lead sponsor of 78 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical condition stable for ≥4 weeks.
  • New York Heart Association functional classification I-II to III
  • Over 18 years old

Exclusion criteria

Exclusion Criteria:

History of CABG surgery

  • Unstable angina pectoris
  • Severe arrhythmia
  • Acute pericarditis, endocarditis, myocarditis
  • Severe left ventricular failure (EF \<40%)
  • Acute pulmonary embolism
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Patients

    İntervention Group: LV-HIIT

    Other: Low-volume, high-intensity interval training

  • Other
    Control group

    Control group

    Drug: Standart medical treatment

Interventions

  • OtherLow-volume, high-intensity interval training

    Low-volume, high-intensity interval training with an arm ergometer will be given two days a week for a total of eight weeks.

  • DrugStandart medical treatment

    Standart medical teatment

06

What researchers measure

Primary outcomes

  1. maximal arm exercises capacity

    maximal arm exercises capacity will measurement with arm ergometer test.

    Time frame: At baseline and after 8 week

  2. Functional capacity

    Functional capacity will be assessed with the six-minute walk test (6MWT).

    Time frame: At baseline and after 8 week

  3. 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.

    Time frame: At baseline and after 8 week

  4. 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

    Time frame: At baseline and after 8 week

  5. cognitive function

    Mini mental Questionaire will use. Min 24 point is the cut of for this test

    Time frame: At baseline and after 8 week

  6. 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

    Time frame: At baseline and after 8 week

  7. heart rate variablity

    Time frame: At baseline and after 8 week

Secondary outcomes

  1. 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.

    Time frame: At baseline and after 8 week

  2. 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.

    Time frame: At baseline and after 8 week

  3. 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.

    Time frame: At baseline and after 8 week

07

Study locations

2 of 2 sites recruiting
  • Tarsus University, TARSUS, Mersin
    Mersin, Mersi̇n, Turkey
    Recruiting
  • Nurel Ertürk, TARSUS, Mersin
    Yeni̇şehi̇r, Mersi̇n, Turkey
    • Nurel Ertürk · Contact · 05056637544
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — All IPD collected throughout the trial, only IPD used in the results publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06754475
Lead sponsor
Tarsus University
Responsible party
Nurel Ertürk (Assist. Prof., Tarsus University) — Principal investigator
First posted
Dec 31, 2024
Start date
Nov 1, 2024
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jan 3, 2025

Study contacts

Nurel ERTÜRK
Contact
nrlbllr@gmail.com
+905056637544

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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