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临床试验/CTRI/2024/12/078331
CTRI/2024/12/078331招募中不适用

INVESTIGATING THE EFFICACY OF AEROBIC AND BREATHING EXERCISE ON NEUROCOGNITIVE, PULMONARY AND AUTONOMIC FUNCTIONS IN SMOKERS

PreetiSainiIndividual1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
315
试验地点
1
主要终点
1 Pulmomary function

研究概览

简要总结

INVESTIGATING THE EFFICACY OF AEROBIC AND BREATHING EXERCISE PROGRAMS ON NEUROCOGNITIVE, PULMONARY AND AUTONOMIC FUNCTIONS IN SMOKERS

INTRODUCTIONSmoking has a direct and foremost impact on quality of life (QOL) and life expectancy. (Goldenberget al., 2014). Further frequent environmental exposure and smoke inhalation might be injurious to health.It is evident that aerobic Exercises and breathing exercises are an effective and established choice of modality to improve Pulmonary function, Autonomic function and Cognitive function in smokers (Erickson et al., 2009).  However, there is Paucity of Studies which have compared and studied the effectiveness of these two-exercise program on improvement in neurocognitive, autonomic and pulmonary Status of the Smokers

Problem statementThere is a lack of studies on the impact of smoking on neurocognitive, pulmonary, and autonomic functions in India. Additionally, no effective programs counteract these deficits among smokers. This study aims to investigate these impacts and determine the effectiveness of two exercise programs

.

Aim of the study:

Phase 1

Aim This study aims to assess the impact of smoking and compare the effectiveness of aerobic exercises versus breathing exercise programs on neurocognitive, pulmonary, and autonomic function.

Objectives of the Study

•        To study the impact of smoking on neurocognitive function among smokers.

•        To study the impact of smoking on pulmonary function in smokers

•        To investigate the impact on autonomic function amongst smokers

•        To compare the neurocognitive, autonomic & pulmonary function among smokers and nonsmokers

 Phase II

           Objectives of the Study•        To investigate the efficacy of aerobic exercise on neurocognitive, pulmonary& autonomic function in smokers•        To evaluate the effect of Breathing exercises neurocognitive, pulmonary& autonomic function in smokers•        To compare the effect of Aerobic versus Breathing exercises neurocognitive, pulmonary& autonomic function in smokersProcedure

Participants will be selected from Tobacco cessation center and OPD at Manav Rachna International institute of Research and studies and from community outreach program by organizing camps. The purpose and procedure of study will be explained to the participants and they will be requested to sign an informed consent. Participants will then be screened as per selection criteria.

At first the demographic data of the participant such as age, height, weight and BMI will be collected. Following this the assessment of neurocognition will be done by MOCA, pulmonary function will be assessed by spirometer and autonomic functions a will be investigated by heart rate variability device

In the second phase of the study, individuals with changes in pulmonary autonomic and neurocognitive functions selected and will constitute sample of the study. Written consent will be obtained from all the participants before the commencement of the second phase, followed by which baseline evaluation will be done one day prior to the intervention (day zero), on all the outcome measures i.e., Neurocognition and pulmonary and autonomic function.

The participants will be randomly allocated into two group’s i.e Moderate Aerobic Intensity exercise   program and Breathing group. Warm up program will be administered to both the groups.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • Inclusion criteria:
  • The sample consists of individuals aged 30-50 years, including current smokers with a smoking history of at least 2 years and non-smokers.
  • Individual willing to participate in the study.

排除标准

  • Individual with respiratory disease other than COPD
  • Individuals suffering from any neurological or vestibular disorders
  • Individuals with presence of any peripheral vascular disease.
  • Individuals with psychosomatic disorder.
  • Persons performing Gym or involved in high impact activity.
  • Any musculoskeletal problem interfering with study
  • Uncontrolled Hypertension
  • Uncontrolled Diabetes Mellitus
  • Diagnosed Cancer Cases
  • Non- cooperative individuals
  • Any other comorbidities interfering with Participation in the study.

结局指标

主要结局

1 Pulmomary function

时间窗: At 0 week and 4 Week

2.Cognition

时间窗: At 0 week and 4 Week

3.Heart rate variability

时间窗: At 0 week and 4 Week

次要结局

  • Time domain hrv(Frequency domain hrv)

研究者

发起方
PreetiSainiIndividual
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Preeti Saini

MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES

研究点 (1)

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