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NCT Number: NCT02210585

Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient

The study was designed to test the following hypotheses:

Main Objective:

To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm).

Secondary Objectives:

To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.

Design:

We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study (NCT01155271).

This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.

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Key information

Conditions

Obesity Body Weight Number of Steps Per Day < 7000 Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Universitaire de Grenoble, Grenoble, France

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About this study

Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance.

For many patients with morbid obesity, the implementation of physical activity programs remains difficult for several reasons including the level of disability and psychosocial causes (the scrutiny of others, depression and poorly adapted equipment).

Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical activity (PA) in treated apneic obese patients with low spontaneous physical activity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese patients with BMI > 35 kg/m²
  • Continuous Positive Airway Pressure (CPAP) treatment and > 4h observance per night to the patient with OSAS (obstructive sleep apnoea syndrome)
  • Patients who give written consent
  • Patients who subscribed social insurance

Exclusion criteria

  • Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
  • Contraindication to exercise
  • Pregnant or breast-feed woman
  • Patients under guardianship
  • Imprisoned patients

Treatment and study plan

rehabilitation

Other

12 weeks : 5 sessions per week (1 supervised session at home every month)

92 weeks : spontaneous training (supervised by phone every month)

Primary outcomes

  1. Change in physical activity

    Time frame: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)

    • Number of steps per day
    • Number of MET (metabolic equivalent of task) per day

Secondary outcomes

  1. Changes in body composition

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)

    Fat mass and fat-mass index as assessed by impedancemetry measurements

  2. Change in arterial stiffness

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)

    Pulse wave velocity

  3. Change in endothelial function

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )

    Peripheral arterial tone (RH-PAT)

  4. Change in plasmatic biomarkers

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )

    Oxidative stress and inflammatory blood parameters

  5. Change in quality of life

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )

    SF-12 questionnaire

  6. Number of cardiovascular events per year

    Time frame: Every year from the 1st to the 2th year

    Questionnaire sent to the patient by mail

  7. Change in other parameters of physical activity

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)

    Energy expenditure (total and during daily activities)

  8. Change in sleep quality

    Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)

    Lying and sleep duration

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo

Acronym: STIMOBIII

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2014
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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