Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery

NCT03325764 | Completed

• 2 other identifiers: HAO 0170132017-A01807-46
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe the effects of sleeve gastrectomy, the most commonly performed bariatric procedure worldwide, on functional capacity, habitual physical activity, physical fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese subjects undergoing bariatric surgery. Functional capacity, physical activity, physical fitness and gait parameters will be objectively assessed and compared among candidates seeking sleeve gastrectomy and 6 months after sleeve gastrectomy.

Conditions

Sleeve Gastrectomy

Keywords

Obesity; bariatric surgery; sleeve gastrectomy; physical activity; movement analysis

Outcome Measures

Primary Outcomes (1)

• functional capacity

  Difference in functional capacity (6-min walk test distance)

  before and 6 months after sleeve gastrectomy

Secondary Outcomes (3)

• habitual physical activity (Actigraph GT3X® and activPAL®)

  before and 6 months after sleeve gastrectomy

• cardiorespiratory fitness ( cycle ergometer )

  before and 6 months after sleeve gastrectomy

• muscle strength ( isokinetic dynamometer (Contrex®))

  before and 6 months after sleeve gastrectomy

Study Arms (1)

sleeve gastrectomy

OTHER

Assessment before and after sleeve gastrectomy

Other: functional assessment

Interventions

functional assessment OTHER

assessment of functional capacity, habitual physical, cardiorespiratory fitness, muscle power and postural stability and gait parameters

sleeve gastrectomy

Eligibility Criteria

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

You may qualify if:

• Female gender
• Age between 18 and 65 years
• Planned obesity treatment by sleeve gastrectomy
• Patient with massive obesity (BMI ≥ 40 kg/m2) or severe obesity (BMI between 35 and 40 kg/m2) with comorbidities
• Written informed consent

You may not qualify if:

• Subject not affiliated with a social security scheme
• Regular follow-up not feasible
• Participation in a structured physical activity program
• Severe orthopedic problems
• Disabling neuropathy
• Recent (\< 6 months) coronary event
• Abnormal cardiac stress test
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

GH-Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• Bellicha A, Giroux C, Ciangura C, Menoux D, Thoumie P, Oppert JM, Portero P. Vertical Jump on a Force Plate for Assessing Muscle Strength and Power in Women With Severe Obesity: Reliability, Validity, and Relations With Body Composition. J Strength Cond Res. 2022 Jan 1;36(1):75-81. doi: 10.1519/JSC.0000000000003432.

  PMID: 32218061 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal study comparing data before bariatric surgery and one year after bariatric surgery

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 30, 2017
• Study Start: November 2, 2017
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)