Effects of Upper Extremity Low Volume HIIT in Heart Failure

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nurel ERTÜRK; Phone Number: +905056637544; Email: nrlbllr@gmail.com

Study Locations

• Turkey
  • Mersi̇n
    • Mersin, Mersi̇n, Turkey
      • Recruiting
      • Tarsus University, TARSUS, Mersin
      • Contact: Nurel Ertürk; Phone Number: 05056637544; Email: nrlbllr@gmail.com
    • Yeni̇şehi̇r, Mersi̇n, Turkey
      • Recruiting
      • Nurel Ertürk, TARSUS, Mersin
      • Contact: Nurel Ertürk; Phone Number: 05056637544

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	Drug: Standart medical treatment; Standart medical teatment
Experimental: Patients; İntervention Group: LV-HIIT	Other: Low-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximal arm exercises capacity	maximal arm exercises capacity will measurement with arm ergometer test.	At baseline and after 8 week
Functional capacity	Functional capacity will be assessed with the six-minute walk test (6MWT).	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.	At baseline and after 8 week
heart rate variablity		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	At baseline and after 8 week
cognitive function	Mini mental Questionaire will use. Min 24 point is the cut of for this test	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	At baseline and after 8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At baseline and after 8 week

Collaborators and Investigators

• Sponsor: Tarsus University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: high intensity interval training; upper extremity; exercises capacity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2024/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All IPD collected throughout the trial, only IPD used in the results publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No