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Active, not recruitingNCT07864363Updated Oct 7, 2026

Rhythmic Auditory Stimulation in Heart Failure Patients

An interventional study of functional capacity and Fatigue and dyspnea in Heart Failure and Functional Capacity, sponsored by Necmettin Erbakan University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Screening

Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study was to investigate the acute effects of rhythmic auditory stimulation (RAS) with metronome on functional capacity, vital signs, perceived fatigue, and dyspnea in patients diagnosed with heart failure. The participants (n=40) were divided into two groups: Group 1 (n=20) and Group 2 (n=20). Group 1 underwent the classic 6-minute walk test (6MWT), followed by a one-hour break, and then the 6MWT with rhythmic auditory stimulation. Group 2 underwent the 6MWT with rhythmic auditory stimulation, followed by a one-hour break, and then the classic 6MWT. Functional capacity was assessed using the 6MWT, vital signs using a digital blood pressure monitor and pulse oximeter, fatigue level using the modified Borg scale, and fatigue and dyspnea levels using the modified Borg scale. Assessments were performed in three stages: before the test, after the test, and during recovery.

Read the detailed description

The aim of this study was to investigate the acute effects of rhythmic auditory stimulation (RAS) with metronome on functional capacity, vital signs, perceived fatigue, and dyspnea in patients diagnosed with heart failure. The participants (n=40) were divided into two groups: Group 1 (n=20) and Group 2 (n=20). Group 1 underwent the classic 6-minute walk test (6MWT), followed by a one-hour break, and then the 6MWT with rhythmic auditory stimulation. Group 2 underwent the 6MWT with rhythmic auditory stimulation, followed by a one-hour break, and then the classic 6MWT. Functional capacity was assessed using the 6MWT, vital signs using a digital blood pressure monitor and pulse oximeter, fatigue level using the modified Borg scale, and fatigue and dyspnea levels using the modified Borg scale. Assessments were performed in three stages: before the test, after the test, and during recovery.

02

Conditions studied

  • Heart Failure
  • Functional Capacity

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03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.

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Lead sponsor

Necmettin Erbakan University is the lead sponsor of 199 studies on the registry; 47 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being 18 years of age or older,

    • Scoring 20 or higher on the Mini Mental Test (Appendix 3) for patients aged 65 and over,
    • Having a clinical diagnosis of heart failure,
    • Being under stable medical treatment,
    • Being at Class II or Class III according to the New York Heart Association (NYHA) functional classification,
    • Volunteering to participate in the study and signing the Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

    • Yürümeyi veya egzersiz testini engelleyecek düzeyde ortopedik.nörolojikveya psikiyatrik hastalık tanısı bulunanlar,

      • Herhangi bir işitme problemi tanısı bulunan ve işitme cihazı kullananlar,
      • Son 1 ay içerisinde akut miyokard enfarktüsü, kardiyojenik şok veya acil koroner revaskülarizasyon gibi akut kardiyak süreçler geçirmiş olmak.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Classic group

    Behavioral: functional capacity · Behavioral: Fatigue and dyspnea

  • Active comparator
    rhythmic group

    Behavioral: functional capacity · Behavioral: Fatigue and dyspnea

Interventions

  • Behavioralfunctional capacity

    First, classic 6 MWT, then 6 MWT with rhythmic auditory stimulation.

  • BehavioralFatigue and dyspnea

    First, 6MWT with rhythmic auditory stimulation then classic 6 MWT.

06

What researchers measure

Primary outcomes

  1. Change in Functional Capacity Assessed by the 6-Minute Walk Test (6MWT)

    Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). The total distance walked in six minutes will be recorded in meters (m). Changes in functional capacity will be evaluated by comparing the distance walked before and one hour after the intervention. An increase in walking distance indicates an increase in functional capacity.

    Time frame: Baseline (before intervention) and one hour after the intervention.

Secondary outcomes

  1. Change in Perceived Fatigue and Dyspnea Measured Using the Modified Borg Scale (0-10)

    The levels of perceived fatigue and dyspnea will be assessed using the Modified Borg Scale, a subjective rating scale ranging from 0 (no symptoms) to 10 (maximal symptoms). Fatigue and dyspnea will be assessed and recorded separately. Changes in fatigue and dyspnea scores will be evaluated by comparing the scores obtained at baseline and one hour after the intervention.It shows that the level of fatigue increases as the score rises.

    Time frame: Baseline (pre-intervention) and one hour after the intervention

07

Study locations

1 site
  • Physical Therapy and Rehabilitation
    Konya, Konya (507) 534-6142, Turkey (Türkiye)
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07864363
Responsible party
hanife dogan (Physıcal Therapy and Rehabilitation, Necmettin Erbakan University) — Principal investigator
First posted
Oct 7, 2026
Start date
Aug 27, 2026
Primary completion
Sep 27, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Oct 7, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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