Comparative Effects of Balance and Inspiratory Muscle Training on Balance, Respiratory Muscle Strength, and Physical Performance in Older Adults: A Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
This study aims to investigate and compare the effects of Inspiratory Muscle Training (IMT), balance training, and a combination of both on respiratory muscle strength and balance in older adults. Aging is often associated with a decline in skeletal and respiratory muscle strength, which can increase the risk of falls and impact overall functionality.
Participants aged 60 and over will be randomly assigned to one of three groups:
Respiratory Muscle Training group (30 breaths, twice daily),
Balance Training group (45-50 minute sessions, 3 days a week),
Combined Training group (both IMT and balance exercises).
The intervention will last for 8-weeks. Researchers will evaluate respiratory muscle strength, balance, core endurance, and functional capacity before and after the 8-week program to determine which approach is most effective in improving these parameters in the geriatric population.
详细描述
This is a 3-arm randomized comparative trial designed to evaluate the synergistic effects of respiratory and physical interventions in the geriatric population. Physiological changes due to aging, such as reduced inspiratory muscle pressure (MIP) and impaired postural control, are closely linked to increased mortality and fall risk. This study tests the hypothesis that combining IMT with balance training will yield superior outcomes compared to single-mode interventions.
Methodology and Interventions:
Participants will be allocated into three groups using block randomization to ensure gender balance (n=12 per group, total target n=36, accounting for a 20% potential attrition rate):
Group 1 (IMT): Participants will perform 30 breaths twice daily using an IMT device for 8 weeks.
Group 2 (Balance): Participants will attend 45-50 minute supervised balance training sessions, 3 days per week for 8 weeks.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60 years or older.
- •Mini-Mental State Examination (MMSE) score of 22 or higher.
- •Ability to walk 10 meters independently without human assistance.
- •Ability to read and write.
- •Volunteering to participate and providing written informed consent.
排除标准
- •Current use of sedative or hypnotic medications.
- •Presence of a diagnosed neurological disorder (e.g., history of stroke, Parkinson's disease, Multiple Sclerosis, dementia, or clinical vertigo) that is currently under treatment.
- •Presence of clinically significant cardiovascular or pulmonary complications (e.g., COPD, active lung disease, or uncontrolled hypertension).
- •Severe postural abnormalities that may interfere with the study (e.g., advanced scoliosis or kyphosis).
- •Acute or chronic orthopedic conditions preventing participation in a balance exercise program (e.g., lower extremity fractures or severe joint instability).
- •High risk of sarcopenia, defined as a SARC-F score of 4 or higher.
- •Significant communication or cognitive barriers that prevent following the exercise instructions.
研究组 & 干预措施
Inspiratory Muscle Training
Participants will perform inspiratory muscle training using a threshold device. The protocol consists of 30 breaths, twice daily (60 breaths total per day), for 7 days a week over a period of 8 weeks.
干预措施: Inspiratory Muscle Training (Device)
Balance Training
Participants will receive a supervised balance training program. The sessions will be held 3 days per week, each lasting 45-50 minutes, for a total duration of 8 weeks.
干预措施: Balance Training (Behavioral)
Combined Training Group (IMT + Balance)
Participants will receive both interventions concurrently. This includes the daily IMT protocol (30 breaths, twice daily) and the supervised balance training sessions (45-50 minutes, 3 days per week) for 8 weeks.
干预措施: Inspiratory Muscle Training (Device)
Combined Training Group (IMT + Balance)
Participants will receive both interventions concurrently. This includes the daily IMT protocol (30 breaths, twice daily) and the supervised balance training sessions (45-50 minutes, 3 days per week) for 8 weeks.
干预措施: Balance Training (Behavioral)
结局指标
主要结局
Maximal Inspiratory Pressure (MIP)
时间窗: Baseline and 8 weeks.
MIP will be measured using a digital pressure gauge to evaluate the strength of the inspiratory muscles. The best of three maneuvers will be recorded in cmH2O. Higher values indicate better respiratory muscle strength.
Maximal Expiratory Pressure (MEP)
时间窗: Baseline and 8 weeks.
MEP will be measured using a digital pressure gauge to evaluate the strength of the expiratory muscles. The best of three maneuvers will be recorded in cmH2O. Higher values indicate better expiratory muscle strength.
Timed Up and Go (TUG) Test
时间窗: Baseline and 8 weeks.
The TUG test measures the time (in seconds) it takes for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Lower scores (less time) indicate better functional mobility and balance.
Respiratory Muscle Endurance (Incremental Threshold Loading Test)
时间窗: Baseline and 8 weeks.
Respiratory muscle endurance will be assessed using an incremental threshold loading test (ITLT). The test starts with an initial load based on the participant's Maximal Inspiratory Pressure (MIP). The resistance is increased by 20% of the initial MIP value every 2 minutes. Participants are instructed to maintain their breathing pattern against the increasing load until exhaustion or until they can no longer overcome the threshold. The total duration (in seconds) sustained during the test is recorded. Higher values indicate better respiratory muscle endurance.
Single Leg Stance Test (SLST)
时间窗: Baseline and 8 weeks.
The participant stands on one leg for as long as possible without support. The time (in seconds) until balance is lost is recorded (up to a maximum of 30 or 60 seconds). Higher values indicate better static balance.
6-Minute Walk Test (6MWT)
时间窗: Baseline and 8 weeks.
The 6MWT measures the total distance (in meters) a participant can walk on a flat, hard surface in a period of 6 minutes. It is used to assess submaximal functional exercise capacity.
Core Muscle Endurance Test
时间窗: Baseline and 8 weeks.
Core endurance will be assessed using static holding test (McGill's torso endurance test). The duration (in seconds) the participant can maintain the position is recorded. Higher duration indicates better core stability.
次要结局
- Short Physical Performance Battery (SPPB)(Baseline and 8 weeks.)
- Charlson Comorbidity Index (CCI)(Baseline.)
- Mini-Mental State Examination (MMSE)(Baseline.)
- Montreal Cognitive Assessment (MoCA)(Baseline.)
- Tinetti Performance-Oriented Mobility Assessment (POMA)(Baseline and 8 weeks.)
- Handgrip Strength(Baseline and 8 weeks.)
- Physical Activity Scale for the Elderly (PASE)(Baseline.)
- Fatigue Impact Scale (FIS)(Baseline.)