NCT01155271

Brief Summary

The study was designed to test the following hypotheses: In obese patients with OSAS, the benefit of the combination of exercise training + continuous positive airway pressure (CPAP) will be higher than CPAP alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life. In obese patients with OSAS, the benefit of training using ventilatory assistance (NIV) during cycloergometer \[cycloergometer with NIV\] or respiratory muscles training (spirotiger) in addition to cycloergometer \[cycloergometer + spirotiger\] will be higher than cycloergometer training alone \[cycloergometer\] in term of functional and exercise capacities. Dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as \[cycloergometer + NIV\] or \[cycloergometer + spirotiger\]

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable obesity

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

4.4 years

First QC Date

June 30, 2010

Last Update Submit

October 1, 2018

Conditions

ObesitySleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Change in exercise tolerance during walking test

    * walking distance * dyspnea score

    After control period (6th wk) vs. after training period (18th wk)

Secondary Outcomes (9)

  • Changes in Aerobic capacity

    After control period (6th wk) vs. after training period (18th and 52th wks)

  • Changes in cardiovascular and metabolic function

    After control period (6th wk) vs. after training period (18th and 52th wks)

  • Changes in sleep parameters and Quality Of life

    After control period (6th wk) vs. after training period (18th and 52th wks)

  • Number of cardiovascular events per year

    Every year from the 1st to the 5th year

  • Changes in body composition

    After control period (6th wk) vs. after training period (18th and 52th wks)

  • +4 more secondary outcomes

Study Arms (2)

ERGO

ACTIVE COMPARATOR

General endurance training on cycloergometer

Other: Rehabilitation

ERGONIV/ ERGOSPIRO

ACTIVE COMPARATOR

General endurance training on cycloergometer using ventilatory assistance (ERGONIV) or additional respiratory muscle training (ERGOSPIRO)

Other: Rehabilitation

Interventions

RehabilitationOTHER

12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home) 1 technical visit and 1 nursing visit every two months at home for the CPAP

ERGOERGONIV/ ERGOSPIRO

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSAS (AHI \> 30 before CPAP treatment)
  • \> 4h/d CPAP treatment adherence
  • Obese patients with 35 \< BMI \< 45 kg/m2
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Québec, GIV 4G5, Canada

Location

Hopital Universitaire de Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • Vivodtzev I, Tamisier R, Croteau M, Borel JC, Grangier A, Wuyam B, Levy P, Minville C, Series F, Maltais F, Pepin JL. Ventilatory support or respiratory muscle training as adjuncts to exercise in obese CPAP-treated patients with obstructive sleep apnoea: a randomised controlled trial. Thorax. 2018 Feb 20:thoraxjnl-2017-211152. doi: 10.1136/thoraxjnl-2017-211152. Online ahead of print.

    PMID: 29463621DERIVED

MeSH Terms

Conditions

ObesitySleep Apnea Syndromes

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jean-Louis Pepin, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

FR(1)CA(1)