Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451601
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-24
Brief Title:
Intermittent Hypoxia-hyperoxia Therapy in Obese Patients IHHTOP
Sponsor:
Balnear and Rehabilitation Sanatorium Techirghiol
Organization:
Balnear and Rehabilitation Sanatorium Techirghiol
Study Overview
Official Title:
The Metabolic and Respiratory Effects of Intermittent Hypoxia-hyperoxia Therapy in Obese Patients Within the Complex Management of Medical Rehabilitation
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IHHTOP
Brief Summary:
Obesity represents the excessive or abnormal accumulation of adipose tissue in the body which affects health through its association with the risk of developing diabetes mellitus cardiovascular and pulmonary diseases and hypertension
Obesity can cause significant respiratory changes so obese patients present pulmonary complications more frequently than individuals with normal weight
Intermittent hypoxia IH represents the alternation between repeated episodes of hypoxia interspersed with normoxic episodes Intermittent hypoxia-hyperoxia is the therapy that uses hyperoxic intervals instead of normoxic ones between hypoxic breathing sessions
This study aimed to evaluate the effectiveness of intermittent hypoxia-hyperoxia therapy among obese patients focusing on metabolic and respiratory effects The study aimed to determine if this method could bring benefits in managing or alleviating the complications associated with obesity
A total of 70 obese patients will be recruited and randomized to either the IHHT group or the control group The intervention group will receive IHHT while the control group will not receive this therapy
All patients will be assessed at baseline and after 2 weeks of treatment using a variety of clinical and functional measures The studys results will be used to determine whether IHHT benefits the patients who follow it
This study is designed to contribute to the existing body of knowledge on treating obese patients The results of the study will be of interest to clinicians researchers and patients
Obesity can cause significant respiratory changes so obese patients present pulmonary complications more frequently than individuals with normal weight
Intermittent hypoxia IH represents the alternation between repeated episodes of hypoxia interspersed with normoxic episodes Intermittent hypoxia-hyperoxia is the therapy that uses hyperoxic intervals instead of normoxic ones between hypoxic breathing sessions
This study aimed to evaluate the effectiveness of intermittent hypoxia-hyperoxia therapy among obese patients focusing on metabolic and respiratory effects The study aimed to determine if this method could bring benefits in managing or alleviating the complications associated with obesity
A total of 70 obese patients will be recruited and randomized to either the IHHT group or the control group The intervention group will receive IHHT while the control group will not receive this therapy
All patients will be assessed at baseline and after 2 weeks of treatment using a variety of clinical and functional measures The studys results will be used to determine whether IHHT benefits the patients who follow it
This study is designed to contribute to the existing body of knowledge on treating obese patients The results of the study will be of interest to clinicians researchers and patients
Detailed Description:
The study was a prospective randomized controlled unicentric study conducted at the Balneal and Rehabilitation Sanatorium Techirghiol BRST in Romania A total of 70 obese patients BMI 30 kgm2 were enrolled in the study The patients were randomly assigned to either the IHHT group or the control group
Patients in the intervention group received intermittent hypoxia-hyperoxia therapy and patients in the control group did not receive this therapy Simultaneously with the intermittent hypoxia-hyperoxia therapy the patients benefited from complex balneo-physical-kinetic treatment which included hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors sapropelic mud and salt water from Lake Techirghiol electrotherapy massage therapy and kinetotherapy
The 35 patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device During the hypoxic phases patients received concentrations of 9-16 O2 while during the hyperoxic phases approximately 35 O2 was administered
During both testing and actual therapy sessions patients remained in a comfortable position lying on a bed Initially patients performed hypoxic tests 1 and 2 to determine the optimal oxygen level and to be included in a typology type I II or III Based on the obtained data the device automatically calculated and planned personalized IHHT sessions for each patient
Starting from the following day patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows hypoxia with 9-16 O2 for 5-7 minutes followed by exposure to hyperoxia with 35 O2 for 2-5 minutes During the sessions both SpO2 and heart rate were constantly monitored using the devices built-in pulse oximeter
In total patients in the IHHT group performed 9 sessions of hypoxic-hyperoxic therapy testing on the first day hypoxic tests 1 and 2 followed by 4 days of sessions in the first week 2 days of rest on the weekend and then another 5 days of sessions in the second week
The initial assessment of patients consisted of a comprehensive medical examination which identified their comorbidities family history verification of medication for associated pathologies and behavioral factors smoking alcohol consumption psychosocial stress
All patients underwent the following measurements resting blood pressure BP heart rate HR blood oxygen saturation SpO2 anthropometric data height cm body weight kg waist circumference cm and hip circumference cm BMI calculation blood sampling urea uric acid creatinine glucose total cholesterol AST ALT Regardless of the presence or absence of changes in the analysis results patients were included in the study We consider it important to investigate the entire spectrum of the studied patients including those with evident changes in their analyses and those with normal results to obtain a comprehensive and representative image of the researched phenomenon The patients also performed a 6-minute walk test and a spirometry
After completing the 2 weeks of treatment at the Balneal and Rehabilitation Sanatorium of Techirghiol the final assessment identified the same parameters as followed initially
The statistical analysis was performed using IBM SPSS statistics software version 25 Data are presented as mean standard deviation SD for continuous variables in case of symmetric distributions median and IQR Interquartile range IQR P75-P25 for numerical discrete variables or for continuous variables in case of skewed distributions or as frequencies and percentages for categorical variables The normality of the continuous data was estimated with Shapiro-Wilk Tests of Normality For hypotheses testing Independent Samples Mann Whitney U test Related Samples Wilcoxon Signed Rank Test Chi-Square Test of association were used depending on the type of analyzed variables Spearmans correlation coefficient was used as a statistical measure of the strength of a relationship between paired data The significance level α was set at 005 If the test statistic for every conducted test was in the critical region and the p-value was less than or equal to the significance level we decided to reject the null hypothesis in favor of the alternative hypothesis
Patients in the intervention group received intermittent hypoxia-hyperoxia therapy and patients in the control group did not receive this therapy Simultaneously with the intermittent hypoxia-hyperoxia therapy the patients benefited from complex balneo-physical-kinetic treatment which included hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors sapropelic mud and salt water from Lake Techirghiol electrotherapy massage therapy and kinetotherapy
The 35 patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device During the hypoxic phases patients received concentrations of 9-16 O2 while during the hyperoxic phases approximately 35 O2 was administered
During both testing and actual therapy sessions patients remained in a comfortable position lying on a bed Initially patients performed hypoxic tests 1 and 2 to determine the optimal oxygen level and to be included in a typology type I II or III Based on the obtained data the device automatically calculated and planned personalized IHHT sessions for each patient
Starting from the following day patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows hypoxia with 9-16 O2 for 5-7 minutes followed by exposure to hyperoxia with 35 O2 for 2-5 minutes During the sessions both SpO2 and heart rate were constantly monitored using the devices built-in pulse oximeter
In total patients in the IHHT group performed 9 sessions of hypoxic-hyperoxic therapy testing on the first day hypoxic tests 1 and 2 followed by 4 days of sessions in the first week 2 days of rest on the weekend and then another 5 days of sessions in the second week
The initial assessment of patients consisted of a comprehensive medical examination which identified their comorbidities family history verification of medication for associated pathologies and behavioral factors smoking alcohol consumption psychosocial stress
All patients underwent the following measurements resting blood pressure BP heart rate HR blood oxygen saturation SpO2 anthropometric data height cm body weight kg waist circumference cm and hip circumference cm BMI calculation blood sampling urea uric acid creatinine glucose total cholesterol AST ALT Regardless of the presence or absence of changes in the analysis results patients were included in the study We consider it important to investigate the entire spectrum of the studied patients including those with evident changes in their analyses and those with normal results to obtain a comprehensive and representative image of the researched phenomenon The patients also performed a 6-minute walk test and a spirometry
After completing the 2 weeks of treatment at the Balneal and Rehabilitation Sanatorium of Techirghiol the final assessment identified the same parameters as followed initially
The statistical analysis was performed using IBM SPSS statistics software version 25 Data are presented as mean standard deviation SD for continuous variables in case of symmetric distributions median and IQR Interquartile range IQR P75-P25 for numerical discrete variables or for continuous variables in case of skewed distributions or as frequencies and percentages for categorical variables The normality of the continuous data was estimated with Shapiro-Wilk Tests of Normality For hypotheses testing Independent Samples Mann Whitney U test Related Samples Wilcoxon Signed Rank Test Chi-Square Test of association were used depending on the type of analyzed variables Spearmans correlation coefficient was used as a statistical measure of the strength of a relationship between paired data The significance level α was set at 005 If the test statistic for every conducted test was in the critical region and the p-value was less than or equal to the significance level we decided to reject the null hypothesis in favor of the alternative hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None