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NCT Number: NCT06754475

Effects of Upper Extremity Low Volume HIIT in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus University, TARSUS, Mersin, Mersin, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Low-volume, high-intensity interval training

Other

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 treatment

Drug

Standart medical teatment

Primary outcomes

  1. maximal arm exercises capacity

    Time frame: At baseline and after 8 week

    maximal arm exercises capacity will measurement with arm ergometer test.

  2. Functional capacity

    Time frame: At baseline and after 8 week

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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. heart rate variablity

    Time frame: At baseline and after 8 week

Secondary outcomes

  1. hand steadness

    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.

  2. Anxiety and depresion

    Time frame: At baseline and after 8 week

    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.

  3. activities of daily living

    Time frame: At baseline and after 8 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nurel ERTÜRK

CONTACT

[email protected]

+905056637544

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

The Effect of Upper Extremity Low-Volume High-Intensity Interval Training on Physical and Cognitive Functions in Heart Failure Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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