Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

26 november 2018 uppdaterad av: Luc Tappy, MD, University of Lausanne

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Sedentarity is a risk factor for overweight, insulin resistance and diabetes mellitus. Several randomized clinical trials have shown that lifestyle interventions including exercise are efficient in improving metabolic homeostasis in overweight and obese patients. This may be related sedentarity being associated with low physical fitness, and to training enhancing it through multiple systems effects (cardiovascular and respiratory systems, central nervous system, osteo-articular system).

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.

Eigtheen male and female subjects, aged 18-50 years, BMI >27 kg/m2 referred to a physical activity intervention by their primary care physician, will be included. 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 5 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 Primary outcome are: GFS (composite of a score of physical endurance, two scores of muscle strength, one score of balance, and one score of osteo-articular mobility) before and after 3 months of intervention.

Secondary outcomes are: physical activity questionnaire, maximal power output; maximal oxygen consumption; fat oxidation; fasting metabolic profile before and after 3 months of intervention.

Studietyp

Observationell

Inskrivning (Förväntat)

18

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Schweiz
    • Fribourg
      • Estavayer le lac, Fribourg, Schweiz, 1470
        • Rekrytering
        • Hôpital Intercantonal de la Broye
        • Kontakt:
          • Virgile Lecoultre, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

  • BMI >27 kg/m2

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Övrig: Physical activity training
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Global Fitness Score before and after 3 months physical training
Tidsram: After 3 month 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Lausanne

Samarbetspartners

Hôpital intercantonal de la Broye, Estavayer-le-lac, Switzerland

Utredare

  • Studiestol: Charly Bulliard, MD, Hopital Intercantonal de la Broye, Estavayer le-lac, Switzerland

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2018

Primärt slutförande (Förväntat)

30 juli 2019

Avslutad studie (Förväntat)

31 oktober 2019

Studieregistreringsdatum

Först inskickad

17 oktober 2018

Först inskickad som uppfyllde QC-kriterierna

26 november 2018

Första postat (Faktisk)

27 november 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 november 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 november 2018

Senast verifierad

1 november 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2018-00147

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Träningsträning

Kliniska prövningar på Physical activity training

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Belarus

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

Prenumerera