Additional Effects of Pilates Breathing and Diaphragmatic Breathing Combined With Moderate Intensity Continuous Cycling Training on Blood Pressure, Chest Expansion, Pulmonary Function and Quality Of Life in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Blood Pressure (SBP and DBP)
研究概览
简要总结
Hypertension or high blood pressure is defined as when the pressure in the blood vessels is too high. According to Joint National Committee 8 (JNC 8) Guidelines, hypertension is defined as systolic blood pressure level of more than ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg. This study aims to study the combined effects of Pilates breathing, Diaphragmatic breathing and Moderate Intensity Continuous Cycling Training on blood pressure, chest expansion, pulmonary function and quality of life. Aerobic physical activity moderate intensity continuous training: (55%- 70% of maximal heart rate (MHR), rate of perceived exertion (RPE) of 11-13 on the Borg scale) continuous training, known as MICT. Pilates breathing exercise enhances lung expansion by focusing on controlled rhythmic breathing methods involving respiratory muscles. Diaphragmatic breathing exercise is slow and controlled deep breathing that has important effects on respiratory system by the modulation of autonomic nervous system. Hypertensive patients will be selected for this study. The study will include three groups. One group will undergo Cycling training with Pilates breathing and the other group will undergo Cycling training with Diaphragmatic breathing and third group will undergo Cycling training only. Before initiating the intervention at the baseline, following outcome measures would be assessed for all the patients: Blood pressure, chest expansion, pulmonary function and quality of life.
详细描述
Hypertension or high blood pressure is defined as when the pressure in the blood vessels is too high. According to Joint National Committee 8 (JNC 8) Guidelines, hypertension is defined as systolic blood pressure level of more than ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg. Elevated blood pressure increases the heart's workload and it causes the heart to work harder and become stiffened and thick. High blood pressure can significantly impact a patient's quality of life. These impacts range from physical limitations and emotional distress to increased risk of severe health issues. Lifestyle modifications and exercise can help counteract its effects. This study aims to study the combined effects of Pilates breathing, Diaphragmatic breathing and Moderate Intensity Continuous Cycling Training on blood pressure, chest expansion, pulmonary function and quality of life. Three Parallel arm randomized control study consisting of three groups each group will contain 15 patients. Selection of subjects will be done by using non-probability purposive sampling technique.The sample size was calculated using G* power software version 3.1. This was determined for difference between two means (one-way ANOVA / Kruskal Wallis test), with significance level of 0.05 and power 0.95, which resulted in 45 participants to be enrolled in the study (15 in each group). Following tools will be used for assessment of outcome measures:
Sphygmomanometer (ICC = 0.91-0.97): To assess systolic and diastolic blood pressure.
Spirometry (ICC: 0.88-0.96): A diagnostic test used to assess lung function and help diagnose, monitor, and manage respiratory conditions. It measures the volume of air a person can inhale and exhale and how quickly they can do so. It measures FVC, FEV1 and FEV1/FVC ratio.
MINICHAL Questionnaire (ICC: 0.88,0.85): A useful and reliable instrument used to assess Quality of Life (QoL) in hypertensive patients. It is a short,16 question, self-administered questionnaire that explores both psychological and somatic aspects related to the impact of hypertension on a person's life.
Borg Scale (ICC: 0.7-0.9) It is a scale to measure rate of perceived exertion, a subjective method to measure the intensity of physical activity.The scale ranges from 6 to 20 with each number corresponding to subjective level of exertion Measuring Tape for Chest Expansion (ICC = 0.82-0.91): To measure chest expansion at xiphoid level Pulse Oximeter (ICC: 0.95): The pulse Oximeter is a non-invasive device, which provide digital readings: heart rate and oxygen saturation.
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)
盲法说明
Participants will be blinded to the allocation of intervention groups. Rndomization will be performed using sealed envelop method to ensure allocation concealment
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically diagnosed patients having Stage 1 hypertension(SBP;140-159 mmHg,DBP:90-99mmHg) and Stage 2 -hypertension(SBP:≥160mmHg,DBP:≥100mmHg) according to JNC 8 Guidelines, referred by a medical specialist or GP or cardiologist from FFH or clinical setups or Hospitals of Rawalpindi/Islambad
- •Patients who are on antihypertensive medications for at least 3 months before study.
- •Age ranging from 20-55 years
- •Both male and female patients.
- •Patients who are willing to participate in exercise regime and are able to -provide informed consent, have not been a part of any exercise regime from the last 6 months and well tolerated for exercise after being screened through PAR-Q+
排除标准
- •Patients with Stage 3 hypertension (SBP: ≥180 mmHg or DBP: ≥110 mmHg) and above hypertension according to JNC 8 Guidelines or Hypertensive Crisis etc.
- •Patients with any severe knee or other orthopedic conditions that can limit exercise performance
- •Patients with uncontrolled hypertension
- •History of any abdominal, orthopedic or spinal surgery that could interfere with core or breathing exercise
- •Neurological or psychiatric disorders
- •Uncontrolled cardiovascular conditions such as arrhythmias or recent myocardial infarction
- •Pregnant women
研究组 & 干预措施
Cycling training with diaphragmatic breathing
Participants will perform moderate-intensity continuous cycling training combined with diaphragmatic breathing exercise three times per week for six weeks.
干预措施: Diaphragmatic Breathing (Other)
Cycling training with Pilates breathing
Participants will perform moderate-intensity continuous cycling training with Pilates breathing exercise three times per week for six weeks.
干预措施: Pilates Breathing (Other)
Cycling training
Participants will perform moderate-intensity continuous cycling training only, three times per week for six weeks.
干预措施: Cycling Training (Moderate-intensity continuous training) (Other)
结局指标
主要结局
Blood Pressure (SBP and DBP)
时间窗: 06 weeks
Evaluation will be performed using a sphygmomanometer to measure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). Measurements will be recorded in millimeters of mercury (mmHg) under standardized conditions after at least 5 minutes of seated rest. Two readings will be taken, and the average value will be used for analysis
Chest Expansion
时间窗: 06 weeks
Evaluation will be performed by measuring chest expansion at the xiphoid level using a measuring tape. Chest circumference will be recorded in centimeters (cm) at maximum inspiration and maximum expiration, and chest expansion will be calculated as the difference between these two measurements. Higher values indicate greater chest wall mobility and improved respiratory function, whereas lower values indicate restricted chest expansion.
Pulmonary Function Test
时间窗: 06 weeks
Evaluation will be performed using a spirometer device according to standard guidelines. The parameters assessed will include Forced Expiratory Volume in 1 second (FEV₁), Forced Vital Capacity (FVC), and FEV₁/FVC ratio. Values will be recorded in liters (L) and as percentage of predicted values (%) based on age, sex, height, and ethnicity. Higher values of FEV₁ and FVC indicate better pulmonary function, while a higher FEV₁/FVC ratio indicates reduced airway obstruction and improved respiratory status.
次要结局
未报告次要终点