Heart FailureNCT07864363
Rhythmic Auditory Stimulation in Heart Failure Patients
A study testing functional capacity and Fatigue and dyspnea in people with Heart Failure and Functional Capacity, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Functional Capacity
- What is being tested?
- functional capacity and Fatigue and dyspnea
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Aug 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Physical Therapy and Rehabilitation
Konya, Konya, (507) 534-6142
About this study
Official title: Acute Effects of Rhythmic Auditory Stimulation on 6-Minute Walk Test Performance and Related Clinical Symptoms in Heart Failure Patients
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.
- Conditions
- Heart Failure, Functional Capacity
- Being tested
- functional capacity, Fatigue and dyspnea
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional capacityBehavioural
First, classic 6 MWT, then 6 MWT with rhythmic auditory stimulation.
Fatigue and dyspneaBehavioural
First, 6MWT with rhythmic auditory stimulation then classic 6 MWT.
| Study group | Role | What they receive |
|---|---|---|
| Classic group | Active comparator | Not described Receives: Behavioral: functional capacity; Behavioral: Fatigue and dyspnea |
| rhythmic group | Active comparator | Not described Receives: Behavioral: functional capacity; Behavioral: Fatigue and dyspnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre-intervention) and one hour after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start27 Aug 2026
- Primary completion27 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanife dogan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864363
- Sponsor's protocol ID
- 6DYTKY
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Rhythmic Auditory Stimulation on 6-Minute Walk Test Performance and Related Clinical Symptoms in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT07864363
- Acronym / sponsor ID
- 6DYTKY
- Conditions
- Heart Failure, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic group | Active comparator | Behavioral: functional capacity, Behavioral: Fatigue and dyspnea |
| rhythmic group | Active comparator | Behavioral: functional capacity, Behavioral: Fatigue and dyspnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years of age or older,
Key exclusion criteria (3 listed)
- • Yürümeyi veya egzersiz testini engelleyecek düzeyde ortopedik.nörolojikveya psikiyatrik hastalık tanısı bulunanlar,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional capacityFirst, classic 6 MWT, then 6 MWT with rhythmic auditory stimulation. | Behavioural | Classic group, rhythmic group |
| Fatigue and dyspneaFirst, 6MWT with rhythmic auditory stimulation then classic 6 MWT. | Behavioural | Classic group, rhythmic group |
Primary outcome
Change in Functional Capacity Assessed by the 6-Minute Walk Test (6MWT)
Time frame: Baseline (before intervention) and one hour after the intervention.
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.
1 secondary outcome
Change in Perceived Fatigue and Dyspnea Measured Using the Modified Borg Scale (0-10)
Time frame: Baseline (pre-intervention) and one hour after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional capacity and Fatigue and dyspnea in people with Heart Failure and Functional Capacity, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Capacity Assessed by the 6-Minute Walk Test (6MWT) (time frame: Baseline (before intervention) and one hour after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.