Comparing Music-Supported and Traditional Aerobic Training in Geriatric Health Outcomes

NCT06980311 | Not Yet Recruiting

• 1 other identifier: 02.05.2025-BezmialemVU
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Geriatric; Aerobic Exercise; Music Therapy; Physiotherapy and Rehabilitation

Outcome Measures

Primary Outcomes (12)

• Heart Rate (beats per minute)

  There will be important measures to evaluate cardiovascular fitness and exercise responses of geriatric individuals. Heart rate will be dynamically monitored during exercise and will be used to evaluate exercise intensity and cardiovascular responses.

  2 months

• Heart Rate Recovery (beats per minute)

  There will be important measures to evaluate cardiovascular fitness and exercise responses of geriatric individuals. Heart rate recovery will be important as an indicator of cardiovascular health by determining the rate at which heart rate returns to normal after exercise and will be measured at 5 and 10 minutes after exercise.

  2 months

• Blood Pressure (mmHg)

  Systolic and diastolic blood pressures will be measured using a standard sphygmomanometer to evaluate cardiovascular response to exercise.

  2 months

• Modified Borg Scale Score

  Subjective symptoms such as fatigue and dyspnea will be assessed using the Modified Borg Scale during exercise (6-20).

  2 months

• Forced Expiratory Volume in 1 Second (FEV1) (% predicted)

  FEV1 refers to the volume of air forcibly exhaled in the first second of a forced breath. It will be measured to evaluate airway obstruction and respiratory capacity, and recorded as a percentage of predicted values based on age, sex, height, and weight. The assessment will be conducted in accordance with American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines using a COSMED MicroQuark spirometer (COSMED, Italy).

  3 months

• Forced Vital Capacity (FVC) (% predicted)

  FVC represents the total amount of air exhaled during the spirometry test. It will be used to assess lung volume and capacity, and values will be recorded as a percentage of the predicted normal based on demographic data. Measurements will be performed in compliance with ATS/ERS standards using the COSMED MicroQuark spirometer (COSMED, Italy).

  3 months

• FEV1/FVC Ratio

  The FEV1/FVC ratio is a key marker in distinguishing obstructive from restrictive pulmonary patterns. This ratio will be calculated and expressed as a unitless value. Testing will follow ATS/ERS spirometry criteria and be performed using a COSMED MicroQuark spirometer (COSMED, Italy).

  3 months

• Peak Expiratory Flow (PEF) (% predicted)

  PEF is the maximum speed of expiration and indicates large airway function. It will be recorded as a percentage of the predicted value and used to monitor bronchial flow capacity and effort. Evaluation will be conducted according to ATS/ERS standards using the COSMED MicroQuark spirometry device (COSMED, Italy).

  3 months

• Forced Expiratory Flow 25-75% (FEF25-75%) (% predicted)

  FEF25-75% measures the average flow rate during the middle half of the forced expiration. It reflects small airway function and early signs of airflow limitation, reported as a percentage of predicted normal values. All measurements will be obtained in line with ATS/ERS guidelines using the COSMED MicroQuark spirometer (COSMED, Italy).

  3 months

• Maximum Inspiratory Pressure (MIP) (cmH₂O)

  MIP will be measured to evaluate inspiratory muscle strength using a portable electronic intraoral pressure measuring device (MicroRPM, Micro Medical; England), in accordance with ATS and ERS criteria. Participants will perform a maximal inspiratory effort (Müller maneuver) for a few seconds through the mouthpiece, and the highest value will be recorded in cmH₂O.

  3 months

• Maximum Expiratory Pressure (MEP) (cmH₂O)

  MEP will be assessed to determine expiratory muscle strength using the same MicroRPM device (Micro Medical; England), following ATS and ERS standards. Participants will perform a maximal expiratory effort (Valsalva maneuver) for a few seconds, and the peak pressure value will be recorded in cmH₂O.

  3 months

• Functional Capacity

  The 6-Minute Walk Test (6 DYT) will be used to assess the submaximal functional capacity of the participants. The aim of the 6-Minute Walk Test is to walk the longest distance possible in a 30-meter corridor in 6 minutes. The 6 DYT will be performed in accordance with the guidelines reported by the American Thoracic Society.

  3 months

Secondary Outcomes (17)

• Body Weight (kg)

  3 months

• Height (cm)

  3 months

• Body Mass Index (BMI) (kg/m²)

  3 months

• Body Fat Percentage (%)

  3 months

• Skeletal Muscle Ratio (%)

  3 months

Study Arms (3)

Traditional Aerobic Exercise Training Group

ACTIVE COMPARATOR

Traditional Aerobic Exercise group will undergo treadmill-based aerobic exercise training under the supervision of a physiotherapist twice a week for a total of 8 weeks.

Other: Aerobic Exercise

Music Therapy-Based Aerobic Exercise Training Group

EXPERIMENTAL

Music Therapy-Based Aerobic Exercise Training group will follow the same treadmill exercise program as the Traditional Aerobic Exercise group. However, during the exercise sessions, music therapy will be applied according to the beats per minute (BPM) ranges. Music will be used throughout the exercise sessions to regulate participants' heart rate and blood pressure, reduce perceived fatigue, enhance motivation, and support rhythmic movement patterns. During training, participants' heart rate and oxygen saturation will be monitored using a fingertip pulse oximeter.

Other: Aerobic exercise with music therapy

Control Group

NO INTERVENTION

Individuals in the control group will be provided with physical activity counseling in line with the physical activity guidelines recommended by the World Health Organization (WHO). Participants will be advised to do at least 150-300 minutes of moderate-intensity aerobic physical activity per week and will be informed about the positive effects of movement on health. Participants will continue their current medical treatments (if any) in accordance with the recommendations of their physicians. All participants will be evaluated at the beginning and end of the study.

Interventions

Aerobic Exercise OTHER

Traditional Aerobic Exercise group will undergo treadmill-based aerobic exercise training under the supervision of a physiotherapist twice a week for a total of 8 weeks. For participant safety, they will be instructed to hold onto the handrails while walking, and proper use of the safety key will be ensured during each session. Using the ULTIMA DC-5000 treadmill, participants will follow an exercise protocol based on the guidelines of the American College of Sports Medicine (ACSM), consisting of: a 10-minute warm-up, a 20-30-minute loading phase at 40-60% of heart rate reserve (moderate-to-vigorous intensity), and a 10-minute cool-down, all performed at 0% incline. Throughout the sessions, participants' heart rate and oxygen saturation levels will be monitored via a fingertip pulse oximeter. Fatigue and dyspnea levels will also be assessed and recorded using the Modified Borg Scale.

Traditional Aerobic Exercise Training Group

Aerobic exercise with music therapy OTHER

Music Therapy-Based Aerobic Exercise Training group will follow the same treadmill exercise program as the Traditional Aerobic Exercise group. However, during the exercise sessions, music therapy will be applied according to the beats per minute (BPM) ranges specified below: Warm-up (10 minutes, BPM: 80-100): Low-intensity walking accompanied by slow-tempo music Loading Phase (20-30 minutes, BPM: 120-140): Moderate-to-high intensity walking accompanied by rhythmic, motivational music Cool-down (10 minutes, BPM: 80-100): Low-intensity walking accompanied by slow-tempo sedative music Music will be used throughout the exercise sessions to regulate participants' heart rate and blood pressure, reduce perceived fatigue, enhance motivation, and support rhythmic movement patterns. During training, participants' heart rate and oxygen saturation will be monitored using a fingertip pulse oximeter.

Music Therapy-Based Aerobic Exercise Training Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Related Publications (4)

• 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.

  PMID: 37671396 BACKGROUND

• 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.

  PMID: 32649395 BACKGROUND

• 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.

  PMID: 21098340 BACKGROUND

• 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.

  PMID: 31657693 BACKGROUND

MeSH Terms

Interventions

Exercise; Music Therapy

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gökhan Can Törpü, PhD(c)

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

• Alis Kostanoğlu, PhD

  Bezmialem Vakif University

  STUDY DIRECTOR

• Muhammed Tunç, MD

  Bezmialem Vakif University

  STUDY CHAIR

Central Study Contacts

Alis Kostanoğlu, PhD

CONTACT

+905434931848; aliskostanoglu@gmail.com

Gökhan Can Törpü, PhD(c)

CONTACT

gokhantrp@yahoo.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: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share