Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

Physical Capacity Clinical Trial

— LEICO  

Official title:

Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593798
• Other study ID #: LEICO
• Status: Completed
• Start date: November 1, 2013
• Est. completion date: May 30, 2016

Study information

• Verified date: August 2018
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lifestyle intervention and physical capacity in patients with morbid Obesity (LEICO)

Description:

It is still uncertainty about which is the most effective lifestyle treatment to reducing body weight and increased quality of life. Increased physical capacity and muscle mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss achieved after lifestyle treatment. However, literature in this area is limited and need better documentation of how, and to what extent increased physical capacity can affect the effect of lifestyle treatment offered to patients in the health service.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Treatment morbidly obese patients (BMI = 40 kg/m2 or BMI 35 to 39.9 kg/m2 with = 1 co morbidity) attending the Vestfold Hospital Trust.

Exclusion Criteria:

• Uncompensated heart failure

• Recent myocardial infarction or stroke (<½ years)

• Severe arrhythmia or heart failure

• Unstable angina pectoris

• Renal failure

• Severe eating disorders

• Active substance abuse

Related Conditions & MeSH terms

• Obesity, Morbid
• Physical Capacity

Intervention

Other:
• Lifestyle
Lifestyle intervention an effect on weight and physical capacity

Locations

Country	Name	City	State
Norway	Telemark University College	Bø
Norway	Vestfold Hospital Trust	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	University college of south-east Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change at 1-year follow up	Can physical capacity before start of a routine medical care have a impact on weight loss at 1-year follow-up.; Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 1-year follow up.; Changes from baseline body weight at 1-year follow up.; Participants receive interventions as part of routine medical care, and studie the effect of the intervention.	Changes from baseline body weight at 1-year follow up.
Primary	Weight change at 12-weeks follow up	Can physical capacity before start of a routine medical care have a impact on weight loss at 12-weeks follow-up.; Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 12-weeks follow up.; Changes from baseline body weight at 12-weeks follow up.; Participants receive interventions as part of routine medical care, and studie the effect of the intervention.	Changes from baseline body weight at 12-weeks follow up.
Secondary	Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test	Can the mean twelve-week change in physical capacity be associated with weight loss.; The maximal oxygen uptake test was performed as an incremental treadmill test on Woodway ELG 55 (Waukesha, Germany) or, for patients with walking restrictions, on an incremental bicycle test (Lode Corival V3, Lode BV, Groningen, Netherlands). Oxygen uptake was registered using the Jaeger oxycon pro ergospirometry test system (Jaeger Oxycon Pro JLAB 5.x, Hoechberg, Germany).; Changes from baseline physical capacity at 12-weeks follow up.	Changes from baseline physical capacity at 12-weeks follow up.