Effect of Inspiratory Muscle Training on Blood Pressure in Young Prehypertensive Adults in Anand Vicinity.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood pressure via sphygmomanometer
研究概览
简要总结
Introduction:
According to the Seventh Report of the Joint National Committee (JNC-7), prehypertension is defined as a systolic blood pressure (BP) of 120-139 mmHg or a diastolic BP of 80–89 mmHg. Individuals with prehypertension are at risk of developing hypertension, it has been suggested that early diagnosis and effective management strategies are essential. A study published in the International Journal of Public Health, which analyzed data from the National Family Health Survey (NFHS-5), found that prehypertension affected 33.7% of the population in India, with varying prevalence across districts among adults aged 18–54 years.
Respiratory interventions have been proposed as a method of lowering blood pressure. Inspiratory muscle training (IMT) is a respiratory training technique in which patients breathe against a load set by their maximum static inspiratory pressure. This approach can improve tolerance and efficiency while reducing the blood pressure.
Need Of The Study:
Many studies indicate that Inspiratory muscle training is effective for patients with hypertension; however to the best of my knowledge, no studies have been conducted on the effect of inspiratory muscle training in prehypertensive young adults. Therefore, this study aims to evaluate the effect of inspiratory muscle training on prehypertensive young adults.
Methodology:
First goal is to identify young adults with prehypertension. A Minimum of 184 or more participants will be scrutinized for prehypertension from various areas within the Anand vicinity including hostels, to recruit participants for the study until the target sample size is achieved. From the recruited participants, 50 individuals with prehypertension will be selected to participate in the training period of the study.
To begin the recruitment process, the investigator will first check participants’ blood pressure (BP) to determine if they fall within the prehypertensive range. The BP assessment will be performed in the following steps:
§ Initial Blood Pressure Measurement:
- BP will be measured using a sphygmomanometer and stethoscope at the brachial artery, in accordance with the American Heart Association guidelines (2020).
- Participants will be seated quietly with their back and arms supported for 5 minutes before measurement.
- Three BP measurements will be taken, with a 1-minute rest between each reading. The average of the last two measurements will be calculated. [8]
§ Eligibility Assessment:
o Those with BP readings in the prehypertension range will be informed about the study and invited to take part in the research. However, before being enrolled, they must consult a physician to confirm their prehypertension status.
- The physician will assess their BP readings and review their medical history to ensure that they fall within the prehypertensive range and meet the study’s inclusion criteria.
- Once the physician confirms the diagnosis of prehypertension, participants will be invited to sign the informed consent form and enroll in the study. After enrolling the eligible participants, we will evaluate the effect of inspiratory muscle training on their prehypertension status. Those included in the study will undergo inspiratory muscle training for a duration of 4 weeks.
The Inspiratory Muscle Training (IMT) program using a device designed to strengthen respiratory muscles. Participants will use a respiratory muscle training device as prescribed, performing specific breathing exercises aimed at strengthening the inspiratory muscles for 4 weeks. In addition to IMT, they will also receive care and precaution pamphlets to help control prehypertension. All IMT sessions will be supervised by researcher to ensure correct technique, provide feedback, and monitor progress.
Duration: 4 weeks
Frequency: 5 days per week
Device: Inspiratory muscle training device (Threshold device) with adjustable resistance settings.
Intensity: 40% of maximal inspiratory pressure (progressively increased weekly)
Maximum inspiratory pressure (PIMAX) was assessed before each supervised training session, and the training device will be set to the appropriate resistance.
Follow-up Assessments: At 2 weeks, repeat measurements of blood pressure and respiratory muscle strength.
Outcome :
Primary Outcome:
- Blood pressure will be determined via sphygmomanometer
Secondary Outcome:
- 6 Minute Walk Test
1. 2. Change in respiratory muscle strength (measured by maximal inspiratory pressure)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Those who are willing to participate
- •Age group – 18-45
- •Pre hypertensive individual (i.e. systolic (120-139) and diastolic (80-89)diagnosed.
- •No history of cardiovascular disease, respiratory disease, or severe musculoskeletal disorders.
排除标准
- •The presence of any comorbidity (such as diabetes, chronic heart failure)
- •For individuals checking their blood pressure for the first time and finding it above the prehypertensive range, that indicates the stage of hypertension.
- •History of cardiovascular disease and severe respiratory conditions.
结局指标
主要结局
Blood pressure via sphygmomanometer
时间窗: Pre and Post of the intervention and during the follow-up session (i.e. 2 weeks)
次要结局
- 6 Min Walk Test(Pre and Post of the intervention and during the follow-up session (i.e. 2 weeks))
- Measurement of maximal inspiratory pressure(Pre and Post of the Intervention and during the follow-up session(i.e. 2 weeks))
研究者
Dr Ashish Gupta
K M Patel institute of Physiotherapy