Effects of Upper Extremity Low Volume HIIT in Heart Failure

NCT06754475 | Recruiting

• 1 other identifier: 2024/17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

High Intensity Interval Training; Heart Failure; Exercises

Keywords

high intensity interval training; upper extremity; exercises capacity

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• heart rate variablity

  At baseline and after 8 week

Secondary Outcomes (3)

• hand steadness

  At baseline and after 8 week

• Anxiety and depresion

  At baseline and after 8 week

• activities of daily living

  At baseline and after 8 week

Study Arms (2)

Patients

EXPERIMENTAL

İntervention Group: LV-HIIT

Other: Low-volume, high-intensity interval training

Control group

OTHER

Control group

Drug: Standart medical treatment

Interventions

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.

Patients

Standart medical treatment DRUG

Standart medical teatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (2)

Tarsus University, TARSUS, Mersin

Mersin, Mersin, Turkey (Türkiye)

RECRUITING

Nurel Ertürk, TARSUS, Mersin

Yenişehir, Mersin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nurel ERTÜRK

CONTACT

+905056637544; nrlbllr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)