Intermittent Hypoxia-hyperoxia Therapy in Obese Patients (IHHTOP)

NCT06451601 | Completed

• 1 other identifier: AndreeaUzun
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 study's 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.

Conditions

Obesity

Keywords

intermittent hypoxia hyperoxia therapy; metabolic effects; respiratory effects; medical rehabilitation

Outcome Measures

Primary Outcomes (2)

• Metabolic effects

  Blood sampling (urea, uric acid, creatinine, glucose, total cholesterol). The Units of Measure for these biomarkers = mg/dL.

  Two measurements, at the beginning of treatment and after 2 weeks of treatment.

• Metabolic effects

  Blood sampling (AST, ALT). The Units of Measure for these biomarkers = U/L.

  Two measurements, at the beginning of treatment and after 2 weeks of treatment.

Secondary Outcomes (2)

• Respiratory effects

  Two measurements, at the beginning of treatment and after 2 weeks of treatment.

• Respiratory effects

  Two measurements, at the beginning of treatment and after 2 weeks of treatment.

Study Arms (2)

IHHT Group

EXPERIMENTAL

IHHT group with 35 patients: The patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device.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). 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. 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. Simultaneously with the intermittent hypoxia-hyperoxia therapy, the patients benefited from complex balneo-physical-kinetic treatment.

Device: Intermittent hypoxia-hyperoxia therapy

Control Group

ACTIVE COMPARATOR

Control group with 35 patients: The control group completed only the comprehensive balneo-physical-kinetic treatment (hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors: sapropelic mud and salt water from Lake Techirghiol, electrotherapy, massage therapy and kinetotherapy), without intermittent hypoxia-hyperoxia therapy, neither real nor simulated.

Device: Intermittent hypoxia-hyperoxia therapy

Interventions

Intermittent hypoxia-hyperoxia therapy DEVICE

Data on demographics and clinical conditions was gathered. The investigators collect the next features: sex, age, occupation, environment, body mass index, nutritional status, abdominal circumference, hip circumference, smoking, alcohol. Also, the patients performed a 6-minute walking test. Other Names: * Hydrokinetotherapy * Hydrothermotherapy * Electrotherapy * Massage therapy * Kinetotherapy

Control Group; IHHT Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with BMI \>30 kg/m2
• aged between 40-75 years
• patients to sign the informed consent form
• patients to be compensated and to have medical treatment for associated pathologies

You may not qualify if:

• BMI \<30 kg/m2
• age under 40 or over 75 years
• refusal to sign the informed consent form
• patients presenting contraindications to intermittent hypoxia-hyperoxia therapy
• patients presenting contraindications to complex medical rehabilitation treatment

Sponsors & Collaborators

• Balnear and Rehabilitation Sanatorium Techirghiol: lead

Study Sites (1)

Balneal and Rehabilitation Sanatorium Techirghio

Techirghiol, Constanța County, 906100, Romania

Location

Related Publications (30)

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assit. Prof. Dr. Ionescu Elena Valentina

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 11, 2024
• Study Start: April 1, 2024
• Primary Completion: May 6, 2024
• Study Completion: May 15, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

RO (1)