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临床试验/NCT06980311
NCT06980311尚未招募不适用

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

Bezmialem Vakif University0 个研究点目标入组 33 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
33
主要终点
Maximum Expiratory Pressure (MEP) (cmH₂O)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Aerobic Exercise (Other)

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.

干预措施: Aerobic exercise with music therapy (Other)

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.

结局指标

主要结局

Maximum Expiratory Pressure (MEP) (cmH₂O)

时间窗: 3 months

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.

Heart Rate (beats per minute)

时间窗: 2 months

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.

Heart Rate Recovery (beats per minute)

时间窗: 2 months

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.

Blood Pressure (mmHg)

时间窗: 2 months

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

Modified Borg Scale Score

时间窗: 2 months

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

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

时间窗: 3 months

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).

Forced Vital Capacity (FVC) (% predicted)

时间窗: 3 months

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).

FEV1/FVC Ratio

时间窗: 3 months

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).

Peak Expiratory Flow (PEF) (% predicted)

时间窗: 3 months

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).

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

时间窗: 3 months

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).

Maximum Inspiratory Pressure (MIP) (cmH₂O)

时间窗: 3 months

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.

Functional Capacity

时间窗: 3 months

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.

次要结局

  • 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)
  • Basal Metabolic Rate (BMR) (kcal/day)(3 months)
  • Postural Stability(3 months)
  • Limits of Stability(3 months)
  • Clinical Test of Sensory Integration of Balance(3 months)
  • Handgrip Strength(3 months)
  • Timed Up and Go Test (TUG)(3 months)
  • 30 Second Sit-to-Stand Test(3 months)
  • Physical Activity(3 months)
  • Depression(3 months)
  • Quality of Life Assessment(3 months)
  • Cognitive Functions(3 months)
  • Exercise Enjoyment(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gökhan Can TÖRPÜ

Principal Investigator

Bezmialem Vakif University

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