Effects of Upper Extremity Low Volume HIIT in Heart Failure

Not Applicable

Recruiting

• Conditions: High Intensity Interval Training; Heart Failure; Exercises
• Interventions: Other: Low-volume, high-intensity interval training; Drug: Standart medical treatment

• Registration Number: NCT06754475
• Lead Sponsor: Tarsus University

Brief 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.

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 Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Study First Posted: 2024-12-31
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	Low-volume, high-intensity interval training	İntervention Group: LV-HIIT
Control group	Standart medical treatment	Control group

Primary Outcome Measures

Name	Time	Method
Upper extremity muscle strength	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.
maximal arm exercises capacity	At baseline and after 8 week	maximal arm exercises capacity will measurement with arm ergometer test.
Functional capacity	At baseline and after 8 week	Functional capacity will be assessed with the six-minute walk test (6MWT).
reaction time	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	At baseline and after 8 week	Mini mental Questionaire will use. Min 24 point is the cut of for this test
Postural sway	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	At baseline and after 8 week

Secondary Outcome Measures

Name	Time	Method
hand steadness	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.
Anxiety and depresion	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.
activities of daily living	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.

Trial Locations

Locations (2)

Tarsus University, TARSUS, Mersin; 🇹🇷 Mersin, Mersi̇n, Turkey

Nurel Ertürk, TARSUS, Mersin; 🇹🇷 Yeni̇şehi̇r, Mersi̇n, Turkey