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

NCT02210585 | Completed DMC

• 1 other identifier: 38RC13.554
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Obesity; Number of Steps Per Day < 7000

Outcome Measures

Primary Outcomes (1)

• Change in physical activity

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

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

Secondary Outcomes (8)

• Changes in body composition

  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)

• Change in arterial stiffness

  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)

• Change in endothelial function

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

• Change in plasmatic biomarkers

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

• Change in quality of life

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

Study Arms (2)

Kneehab®

ACTIVE COMPARATOR

5 sessions per week

Other: Rehabilitation

Placebo

PLACEBO COMPARATOR

5 sessions per week

Other: Rehabilitation

Interventions

Rehabilitation OTHER

12 weeks : 5 sessions per week (1 supervised session at home every month) 92 weeks : spontaneous training (supervised by phone every month)

Kneehab®; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to exercise
• Pregnant or breast-feed woman
• Patients under guardianship
• Imprisoned patients

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (3)

Hôpital Universitaire de Grenoble

Grenoble, 38043, France

Location

Hôpital universitaire de Lyon

Lyon, 69310, France

Location

Hôpital universitaire de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Renaud TAMISIER, Pr

  Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 6, 2014
• Study Start: April 9, 2014
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

FR (3)