Clinical trial NCT06980311: Comparing Music-Supported and Traditional Aerobic Training in Geriatric Health Outcomes
Official title: Comparison of the Effects of Music Therapy-Based Aerobic Exercise and Traditional Aerobic Exercise Training on Cardiopulmonary Functions, Functional Capacity, Balance, Peripheral Muscle Strength, Cognitive Functions, Depression, and Quality of Life in Geriatrics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Geriatric
Aerobic Exercise
Music Therapy
Physiotherapy and Rehabilitation
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to comparatively evaluate the effects of a music therapy-based aerobic exercise program and traditional aerobic exercise training on cardiopulmonary functions, functional capacity, balance, peripheral muscle strength, cognitive functions, depression level and quality of life in geriatric individuals.


Eligibility criteria: Inclusion Criteria:

* Being 65 years of age or older
* Willingness to participate in the study

Exclusion Criteria:

* Presence of uncontrolled hypertension (≥180/110 mmHg) or severe complications of diabetes (e.g., diabetic neuropathy, proliferative retinopathy, uncontrolled hypoglycemic episodes)
* Presence of respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD), asthma, etc.
* Presence of chronic neurological disorders such as Multiple Sclerosis (MS), Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS), etc.
* Diagnosis of any oncological disease
* Presence of acute musculoskeletal conditions that would prevent participation in exercise (e.g., fracture, advanced osteoarthritis, severe musculoskeletal injuries)
* Having undergone any surgical operation within the past 6 months
* Presence of visual or auditory impairments that could interfere with the assessment procedures
* A score of ≤24 on the Mini-Mental State Examination (MMSE), indicating cognitive impairment
* Participation in a regular exercise program within the last six months

Primary outcomes:
measure: Heart Rate (beats per minute)
timeFrame: 2 months
measure: Heart Rate Recovery (beats per minute)
timeFrame: 2 months
measure: Blood Pressure (mmHg)
timeFrame: 2 months
measure: Modified Borg Scale Score
timeFrame: 2 months
measure: Forced Expiratory Volume in 1 Second (FEV1) (% predicted)
timeFrame: 3 months
measure: Forced Vital Capacity (FVC) (% predicted)
timeFrame: 3 months
measure: FEV1/FVC Ratio
timeFrame: 3 months
measure: Peak Expiratory Flow (PEF) (% predicted)
timeFrame: 3 months
measure: Forced Expiratory Flow 25-75% (FEF25-75%) (% predicted)
timeFrame: 3 months
measure: Maximum Inspiratory Pressure (MIP) (cmH₂O)
timeFrame: 3 months
measure: Maximum Expiratory Pressure (MEP) (cmH₂O)
timeFrame: 3 months
measure: Functional Capacity
timeFrame: 3 months
Secondary outcomes:
measure: Body Weight (kg)
timeFrame: 3 months
measure: Height (cm)
timeFrame: 3 months
measure: Body Mass Index (BMI) (kg/m²)
timeFrame: 3 months
measure: Body Fat Percentage (%)
timeFrame: 3 months
measure: Skeletal Muscle Ratio (%)
timeFrame: 3 months
measure: Basal Metabolic Rate (BMR) (kcal/day)
timeFrame: 3 months
measure: Postural Stability
timeFrame: 3 months
measure: Limits of Stability
timeFrame: 3 months
measure: Clinical Test of Sensory Integration of Balance
timeFrame: 3 months
measure: Handgrip Strength
timeFrame: 3 months
measure: Timed Up and Go Test (TUG)
timeFrame: 3 months
measure: 30 Second Sit-to-Stand Test
timeFrame: 3 months
measure: Physical Activity
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Quality of Life Assessment
timeFrame: 3 months
measure: Cognitive Functions
timeFrame: 3 months
measure: Exercise Enjoyment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem Vakif University
name: Gökhan Can Törpü, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Alis Kostanoğlu, PhD
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Muhammed Tunç, MD
role: STUDY_CHAIR
References:
citation: Park KS, Buseth L, Hong J, Etnier JL. Music-based multicomponent exercise training for community-dwelling older adults with mild-to-moderate cognitive decline: a feasibility study. Front Med (Lausanne). 2023 Aug 21;10:1224728. doi: 10.3389/fmed.2023.1224728. eCollection 2023.
citation: Chan SY, Chen CF. Effects of an Active Music Therapy Program on Functional Fitness in Community Older Adults. J Nurs Res. 2020 Oct;28(5):e111. doi: 10.1097/JNR.0000000000000391.
citation: Trombetti A, Hars M, Herrmann FR, Kressig RW, Ferrari S, Rizzoli R. Effect of music-based multitask training on gait, balance, and fall risk in elderly people: a randomized controlled trial. Arch Intern Med. 2011 Mar 28;171(6):525-33. doi: 10.1001/archinternmed.2010.446. Epub 2010 Nov 22.
citation: Estebsari F, Dastoorpoor M, Khalifehkandi ZR, Nouri A, Mostafaei D, Hosseini M, Esmaeili R, Aghababaeian H. The Concept of Successful Aging: A Review Article. Curr Aging Sci. 2020;13(1):4-10. doi: 10.2174/1874609812666191023130117.