NCT07417748

Brief Summary

The aim of this study is to determine the possible effect of kinesthetic brain exercises on cognitive function in patients with heart failure. The study will include 40 volunteer individuals aged 30-65 years who have been diagnosed with heart failure in the Cardiology Department and are followed up with a physiotherapy program. Individuals will be randomized into a kinesthetic brain exercise program group (n=20) and a control group (n=20). The control group will receive routine medication monitoring as well as a routine physiotherapy program. The education group will receive routine medication monitoring and a routine physiotherapy program, in addition to individual kinesthetic brain exercise training. Kinesthetic brain exercises will be performed for 30 minutes, 2 days a week for 8 weeks. Demographic information of the individuals will be collected; age, gender, body mass index, age at diagnosis, ejection fraction ratio, family history, smoking status (years/pack). Cognitive function; The Montreal Cognitive Assessment Scale (MoCA), quality of life using the Minnesota Heart Failure Living Questionnaire, and cognitive performance using the Standardized Minimental Test (SMMT) will be used for evaluation. Biochemical analyses will be performed using the Brain-Derived Neurotrophic Factor (BDNF) ELISA kit. Patients in both groups will be evaluated by a physiotherapist before the study and at week 8.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

February 11, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Expected
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 11, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

Heart failurecognitive function

Outcome Measures

Primary Outcomes (3)

  • Cognitive Function

    Cognitive function will be assessed using the Montreal Cognitive Assessment Scale (MoCA). The MoCA was developed as a rapid screening test for mild cognitive impairment. The MoCA assesses various cognitive functions, including attention and concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation, and orientation. The test is scored between 0 and 30 points. A score of 21 or higher is considered normal.

    Initially and after 8 weeks

  • Biochemical analyses

    Brain-derived neurotrophic factor (BDNF) will be examined through biochemical analyses.

    Initially and after 8 weeks

  • Cognitive Performance

    The Standardized Mini-Mental Test (SMMT) will be used to assess cognitive performance. Test scores range from 0 to 30. The threshold for the Mini-Mental Test is 22-23 for educated individuals and 18-19 for uneducated individuals. In assessments for individuals with dementia, scores between 25-30 indicate normal cognitive function, 21-24 indicate mild dementia, 10-20 indicate mild-to-moderate dementia, and 0-9 indicate advanced dementia.

    Initially and after 8 weeks

Secondary Outcomes (1)

  • Quality of life in heart failure

    Initially and after 8 weeks

Study Arms (2)

Exercise

EXPERIMENTAL
Other: Kinesthetic brain exercisesOther: Cardiorespiratory PhysiotherapyDrug: Heart Failure drugs

Control

ACTIVE COMPARATOR
Other: Cardiorespiratory PhysiotherapyDrug: Heart Failure drugs

Interventions

Kinesthetic brain exercises are a series of movements designed to connect the body and mind, encourage the use of brain hemispheres through physical and mental strategies, and also improve and strengthen cognitive functions for learning.

Exercise

This is the standard physiotherapy procedure applied to patients with heart failure. It includes practices aimed at improving breathing, improving respiratory muscle strength, and providing mobilization. It encompasses breathing exercises, functional mobility exercises, stretching and flexibility exercises for the upper and lower extremities, etc.

ControlExercise

Continued use of medications prescribed by the cardiologist, under the supervision of the doctor.

ControlExercise

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with heart failure
  • Between 30-65 years of age
  • No history of cardiac surgery
  • Cooperative patients

You may not qualify if:

  • Diagnosed with or having a history of neurological disease
  • Pregnant or suspected of being pregnant
  • Scoring above 24 on the Mini Mental Test
  • Patients for whom exercise is contraindicated
  • Individuals with a history of orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Karsiyaka, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 11, 2026

Primary Completion

April 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations