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Fostering Exercise After Bariatric Surgery (FREEBASE)

26 kwietnia 2021 zaktualizowane przez: Lia Bally

While the benefits of engagement in regular physical activity after bariatric surgery has been established in various studies, little is known about the effectiveness of an interdisciplinary intervention including nutritional and psychological advice, hands-on training experience and motivational education to promote long-term adherence to a self-motivated active lifestyle in the bariatric surgery population.

This randomized pilot intervention study called Fostering Exercise After Bariatric Surgery (FREEBASE) explores the efficacy of an interdisciplinary approach to promote physical activity-related health competence and an active lifestyle after bariatric surgery.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Bariatric surgery is quickly emerging as a standard treatment for people with obesity stage II and III (BMI ≥35 kg/m2) because of its beneficial long-term effects on body weight and obesity-related comorbidities. In Switzerland, approximately 5,000 bariatric surgeries are performed every year. There is a growing body of evidence demonstrating that engagement in physical activity benefits the bariatric surgery population in many aspects. These entail the prevention of surgery-induced metabolic complications such as sarcopenia and osteopenia on the one hand, but also the mitigation against the commonly observed weight regain and relapse of metabolic comorbidities. Despite these obvious health benefits, inactivity and poor health literacy are common problems amongst people who underwent bariatric surgery. Although the Swiss healthcare system offers well designed post-operative follow-up programmes, exercise is currently not to being considered. Additionally the lower educational level of bariatric surgery patients is a well known problem. Addressing physical activity-related health competence and self-empowerment in this population currently remains an unmet need.

Previous studies investigating exercise interventions in the bariatric surgery population have demonstrated efficacy on metabolic outcomes but also indicated that adherence wanes over time. To overcome the challenge of changing lifestyle in a sustainable way, individuals need to have a complex set of abilities, skills, knowledge, motivation and willingness. In Germany, diverse models have been developed to describe this specific set of competences, all inspired by the concept of health literacy, which is internationally recognised in research and clinical practice.

Physical activity-related health competence comprises three components: (1) Movement competence, enabling individuals to meet the movement-related requirements of physical activities (e.g. motor abilities, motor skills for cycling or gymnastics) (2) control competence for physical activity enabling people to gear their own activity to achieve positive effects in health and well-being, and (3) physical activity-specific self-regulation competence enabling individuals to be regularly active, which involves both motivational and volitional factors. The relevance of physical activity-related health competence for the promotion of an active lifestyle has been demonstrated in various studies in healthy and physical inactive adults at metabolic risk. However, the concept has not yet been addressed in the bariatric surgery population. The investigators therefore hypothesize, that targeting the various components of physical activity-related health competence by means of a comprehensive exercise programme has the potential to result in a more effective promotion of physical activity in the bariatric surgery population, thereby benefitting their long-term health and well-being.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Szwajcaria
      • Bern, Szwajcaria, 3010
        • Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Aged ≥18 years
  • Bariatric surgery within the past 1-6 months according to the guidelines of the Swiss Society for the Study of Morbid Obesity and Metabolic Disorders (SMOB)
  • Willingness to comply with study-related activities
  • Literate in German

Exclusion Criteria:

  • Incapacity to give informed consent
  • Contraindication to participation in the study exercise programme as judged by the clinical investigator or treating physical
  • Physical or physiological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the clinical investigator or treating physical
  • Evidence of malnutrition as judged by the clinical investigator or treating physician
  • Pregnancy, planned pregnancy, or breast feeding (females of childbearing potential are advice to use safe-contraception for up to 18 months post-bariatric surgery as part of usual care)
  • Illicit or prescription drug abuse

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental Group
The experimental group will participate in a 3-months training programme focusing on health competence related outcomes.
Behawioralne: FREEBASE exercise programme

The exercise programme will be initialized 1-10 months following bariatric surgery and last for 3 months. The programme will be mainly delivered in two groups consisting of 10-12 subjects each and will be held in the facilities of a fitness studio and remotely at home. The programme consists of 24 units (two per week, the lesson in the fitness studio lasting for 75 minutes and the remote lesson lasting for 45 minutes.This is due to the COVID-19-related social distancing restrictions. The intervention combines the following elements: a) exercise training in a group, b) interactive workshops on basic knowledge of training sciences and techniques of behavior change and c) an individual exercise counselling session.

The programme will be medically supervised and the content will be taught and instructed by members of the research team qualified in exercise science and sports physiology.
Brak interwencji: Control Group
The control group does not participate in the exercise programme but undergoes identical outcome assessments.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in physical activity-related health competence.
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
The physical activity-related health competence will be assessed using items from different areas (self-efficacy, self-control, emotional attitudes, cognitive attitudes, motivational competence, control of physical load, affect regulation). A composite score will be calculated as the mean score of the individual areas. For each area, the mean score of its items assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (does apply exactly) will be calculated.
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Relative change from baseline in physical activity level.
Ramy czasowe: Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).
Physical activity level will be assessed using accelerometry and is defined as the overall daily mean acceleration (mg).
Physical activity will be measured during one week at baseline and during one week at follow-up (visit 3, at 16-18 weeks).
Change from baseline in self-reported physical activity.
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Self-reported physical activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire "Bewegungs- und Sportaktivität Fragebogen; BSA-F". This questionnaire asks for frequency and duration of daily physical activities such as walking, cycling, garden work, house work, caring for others in the last four weeks. The frequency and duration for each question are multiplied and the products are added up in an overall physical activity index (in minutes/week).
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Change from baseline in self-reported sport and exercise activity.
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Self-reported sport and exercise activity will be assessed using the German Physical Activity, Exercise, and Sport Questionnaire "Bewegungs- und Sportaktivität Fragebogen; BSA-F". This questionnaire includes questions about regular exercise and sport activities. People can indicate up to three exercise and sport activities and indicate frequency and duration in the last four weeks. The frequency and duration for the named exercise and sport activity are multiplied and the products are added up to an exercise and sport activity index (in minutes/week).
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Absolute change in 6-min walking distance (m)
Ramy czasowe: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
Absolute change in Time (s) in the "Timed up and go" test.
Ramy czasowe: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
Absolute change in Time (s) in the "Unilateral hip bridge" test
Ramy czasowe: The test will be conducted at baseline and at visit 2 (after 10-12 weeks).
The test will be conducted at baseline and at visit 2 (after 10-12 weeks).

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in health status
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
The health status will be assessed using the German questionnaire for health status assessment "Allgemeiner Gesundheitszustand"
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Change from baseline in vitality.
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Vitality will be assessed using the German questionnaire "Vitalitätsskala" ("subjective vitality scale") on a 7-point Likert scale ranging vom 1 (not applicable at all) to 7 (very applicable).
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Change from baseline in self-concordance.
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
The self-concordance will be assessed on a 6-point Likert scale ranging from 1 (does not apply at all) to 6 (applies exactly).
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Change from baseline in the intention to perform physical activity.
Ramy czasowe: The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
The intention to perform physical activity will be assessed on a 10-point Likert scale ranging from 1 (I have no such intention) to 10 (I have this intention very strongly).
The questionnaires will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at the follow-up (visit 3, at 16-18 weeks).
Participant satisfaction.
Ramy czasowe: Within the first week after completion of the exercise program.
The satisfaction will be assessed using a self-designed feedback questionnaire. The overall satisfaction is assessed on a 5-point Likert scale ranging from 1 (not satisfied at all) to 5 (very satisfied).
Within the first week after completion of the exercise program.
Perception of usefulness of the program.
Ramy czasowe: Within the first week after completion of the exercise program.
The usefulness will be assessed on a 5-point Likert scale ranging from 1 (not useful at all) to 5 (very useful).
Within the first week after completion of the exercise program.
Change from baseline in self-regulation competence.
Ramy czasowe: The questionnaire will be completed at baseline, after completion of the exercise program (at 10-12 weeks) and at follow-up (at 16-18 weeks).
The self-regulation competence will be calculated as the mean score of the items "self-efficacy", "self-control", "emotional attitudes", "cognitive attitudes", and "motivational competence". Each item is assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (applies exactly).
The questionnaire will be completed at baseline, after completion of the exercise program (at 10-12 weeks) and at follow-up (at 16-18 weeks).
Change from baseline in control competence
Ramy czasowe: The questionnaire will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at follow-up (visit 3, at 16-18 weeks).
The control competence will be calculated as a mean score of the items "control of physical load" and "affect regulation". Each item is assessed on a 5-point Likert scale ranging from 1 (does not apply at all) to 5 (applies exactly).
The questionnaire will be completed at baseline, after completion of the exercise program (visit 2, at 10-12 weeks) and at follow-up (visit 3, at 16-18 weeks).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Lia Bally

Śledczy

  • Główny śledczy: Lia Bally, MD, PhD, University Hospital Bern & University of Bern, Bern, Switzerland

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 lipca 2020

Zakończenie podstawowe (Rzeczywisty)

17 stycznia 2021

Ukończenie studiów (Rzeczywisty)

23 kwietnia 2021

Daty rejestracji na studia

Pierwszy przesłany

16 kwietnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 maja 2020

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 kwietnia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 kwietnia 2021

Ostatnia weryfikacja

1 kwietnia 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • FREEBASE

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Aktywność fizyczna

Badania kliniczne na FREEBASE exercise programme

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