NCT02083913

Brief Summary

The aim of our study is to evaluate the feasibility of a supervised training session using telehealth in the "Clinique medico-chirurgicale du traitement de l'obésité de Sherbrooke" (CMCTO) and its impact on health, physical fitness, quality of life and satisfaction of subjects. 6 subjects awaiting bariatric surgery will be recruited. In addition to usual care, subjects will perform additional sessions of supervised endurance and resistance exercise training. Subjects will be instructed to perform two supervised exercise sessions per week with telehealth plus one without supervision during 12 weeks. The following outcomes will be assessed before and after the telePreSET, then 12 months after bariatric surgery: 1- physical fitness (6MWT, maximal strength, symptom-limited cardiac exercise test); 2-health related quality of life (Laval questionnaire); 3-weight, height, body composition (bioelectrical impedance scale); 4-comorbidities and metabolic parameters (files and blood samples); 5-exercise beliefs (Physical Exercise Belief questionnaire); 6-physical activity (GPAQuestionnaire and actimeter). The feasibility will be assessed with a satisfaction questionnaire concerning physical activity management, dropout and compliance rates, as well as the number of injuries and accidents. The results of this research will give us preliminary data for future projects in order to improve support of bariatric surgery candidates to assure optimal results for their health. Also, we will contribute to the advancement of scientific knowledge, absent in the current literature in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

March 4, 2014

Last Update Submit

October 10, 2018

Conditions

Keywords

Severely obeseBariatric surgeryPhysical activityPhysical fitnessTelehealthQuality of life

Outcome Measures

Primary Outcomes (1)

  • Changes in physical fitness

    6-minutes walking test distance (meter) treadmill symptom-limited cardiac exercise test (METs)

    baseline, then 12 weeks after exercise training and one year after surgery

Secondary Outcomes (8)

  • Changes in quality of life scores

    baseline, then 12 weeks after exercise training and one year after surgery

  • Changes in energy expenditure

    baseline, then 12 weeks after exercise training and one year after surgery

  • Changes in weight (kg)

    baseline, then 12 weeks after exercise training and one year after surgery

  • Changes in exercise beliefs

    baseline, then 12 weeks after exercise training and one year after surgery

  • Final satisfaction

    12 weeks after exercise training

  • +3 more secondary outcomes

Study Arms (1)

Supervised physical activity

EXPERIMENTAL
Behavioral: Telehealth supervised exercise training

Interventions

Endurance and strength training (3x/week during 12 weeks)

Supervised physical activity

Eligibility Criteria

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

You may qualify if:

  • bariatric surgery candidate : morbid obesity (BMI\>40)or severe obesity (BMI\>35 with complications; \> 18 years old)
  • follow usual care in the "Clinique médico-chirurgicale du traitement de l'obésité du Centre Hospitalier Universitaire de Sherbrooke (CHUS)" and ready to do pre-surgery evaluation (approximately 3 month before surgery)
  • no more than one supervised exercise training per week
  • inability to come regularly to the CHUS to participate in supervised exercise training
  • sufficient space to train at home (4m2)

You may not qualify if:

  • medical contraindication for physical activity
  • major functional limitations: failure to realize the 6 minutes walking test
  • intellectual disability and / or neuropsychological disease
  • not being able to speak or understand french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • Baillot A, Mampuya WM, Comeau E, Meziat-Burdin A, Langlois MF. Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg. 2013 Jul;23(7):882-91. doi: 10.1007/s11695-013-0875-5.

    PMID: 23430477BACKGROUND

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Marie-France Langlois, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2018

Last Updated

October 15, 2018

Record last verified: 2017-10

Locations