Follow-Up of Fitness in Overweight Patients Treated With Physical Activity

NCT03754478 | Unknown

• 1 other identifier: 2018-00147
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Although there is increasing evidence that low physical fitness is a risk factor for many non-communicable diseases, the early identification of subjects at risk remains inadequate due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For the same reason, the monitoring of subjects following lifestyle interventions remains suboptimal. The aim of this study is to develop a simple field tool to non-invasively assess global physical fitness in overweight patients participating to a physical activity program. Male and female overweight subjects referred to a physical activity intervention by their primary care physician will be included. Within this program, they will take part to 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration. In addition, participants will take part to teaching sessions in group of 4-6 patients, addressing the effects of physical activity on metabolism, contra-indications to physical activity, self-monitoring of exercise, and prevention of injuries Their physical fitness will be assessed at inclusion (ie before starting the exercise program) and at the end of the 3-month program. This will be done by calculating a Global Fitness Score (GFS) based on performances attained and cardiovascular responses observed during physical exercises (3 min step test with measurement of heart rate and blood pressure, number of time subject can stand from a chair within 1 min., handgrip strength measure, "reach-test" to assess osteo-articular mobility of back and hips, balance test). Results obtained from this GFS will be compared to maximal power output calculated from a submaximal spirometry at 25, 50, 75 and 100 W M.

Conditions

Exercise Training; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Global Fitness Score before and after 3 months physical training

  Global fitness score ranges between 0 (very low fitness) and 30 (optimal fitness). It is calculated as the sum of scores obtained with 5 simple field tests (Chester step test, score 0-10; handgrip, score 0-5; sit-and stand test, score 0-5; Sit and reach test, score 0-5; Flamingo test, score 0-5)

  After 3 month physical training

Study Arms (1)

overweight subjects

Overweight male and females referred to a physical activity program by their primary care physician Intervention is being included in a 3-month physical activity training program

Other: Physical activity training

Interventions

Physical activity training OTHER

subjects will enter a 3-month supervised physical activity program during which they will take part to supervised and unsupervised physical activity sessions. Type of physical activity will be selected among a number of available activities (aquagym, aerobics, resistance training, outdoors activities) based on individual needs and preferences); it will consist in 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration.

overweight subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Overweight subjects referred to a physical activity intervention by their primary care physician

You may qualify if:

• BMI \>27 kg/m2

You may not qualify if:

• cardio-respiratory diseases
• severe osteo-articular diseases
• any condition associated with contra-indication to exercise.

Sponsors & Collaborators

• University of Lausanne: lead
• Hôpital intercantonal de la Broye, Estavayer-le-lac, Switzerland: collaborator

Study Sites (1)

Hopital Intercantonal de la Broye

Estavayer-le-Lac, Canton of Fribourg, 1470, Switzerland

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Charly Bulliard, MD

  Hopital Intercantonal de la Broye, Estavayer le-lac, Switzerland

  STUDY CHAIR

Central Study Contacts

Luc Tappy, MD

CONTACT

+41 21 692 55 41; luc.tappy@unil.ch

Virgile Lecoultre, PhD

CONTACT

+41 26 664 71 11; virgile.lecoultre@hibroye.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Luc Tappy

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 27, 2018
• Study Start: October 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: October 31, 2019
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

CH (1)