Aktiv i Sør: a Randomized Controlled Trial (AiS)
23 maja 2017 zaktualizowane przez: Monica Klungland Torstveit, University of Agder
The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial
The purpose of this regional parallel-group RCT was to assess the effect of a six-month tailored telephone and email based physical activity intervention on various measures of physical fitness and body composition in a sample of physically inactive adults.
A total of 111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either an intervention group (IG;n=56) or a no-intervention control group (CG;n=55).
The IG received tailored exercise recommendations, every two months by email or mail (print) in addition to motivational follow-ups every second week, alternatively by email and telephone.
Primary outcome measures were various objective measures of musculoskeletal and cardiorespiratory fitness in addition to various measures of body composition, including waist circumference, body mass index and fat percentage, which were assessed pre- and post-intervention.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
111
Faza
- Nie dotyczy
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
40 lat do 55 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
Participants were included in the study if they were
- healthy
- between the ages of 40-55
- residents of the Agder counties in Norway
- classified as physically inactive (not fulfill the recommendations for physical activity given by the Norwegian Directorate of Health
- within stage one to three of the five stages of change in the transtheoretical model stages of change
Exclusion Criteria:
Participants were excluded if they were
- Unhealthy/ill
- younger than 40 years or older than 55 years
- living outside the Agder counties in Norway
- allready fulfilling the national recommendations given by the Norwegian Directorate of Health
- within stage four or five of the five stages of change in the transtheoretical model stages of change
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: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Intervention group - telephone and print exercise intervention
The intervention group (IG) received a total of three intervention packages, one every second month, during the intervention period.
The first intervention package was distributed at intervention start.
The intervention package consisted of a tailored exercise program, national recommendations for physical activity, prompts and reminders.
Additionally the IG received fortnightly supportive motivational contact every two weeks, alternately by telephone og email
|
Intervention has previously been described.
|
|
Brak interwencji: Control group
The control group (CG) were encouraged to continue previous lifestyle.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from Baseline Cardiorespiratory fitness at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Cardiorespiratory fitness was measured by a modified Balke protocol on a treadmill and registered in ml/kg/min
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Muscular endurance of the back extensors at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
The static back extension test recorded muscular endurance of the back extensors as number of seconds the subject managed to endure a static horizontal position, with their lower body supported by a bench (max 240 sec).
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Hand grip strength at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Hand grip strength was registered to the nearest 1 kilogram (kg) using a hydraulic dynamometer
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Neuromotor fitness at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Neuromotor fitness was registered using the one leg standing test where the duration each subject managed to hold a balancing position was recorded in seconds (max 60 seconds).
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Muscular dynamic endurance of and the ability to stabilize the upper body at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Muscular dynamic endurance of and the ability to stabilize the upper body was registered using a modified push-ups test.
The amount of correctly performed repetitions completed in 40 seconds, was recorded in number.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Flexibility of the hamstring musculature at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Flexibility of the hamstring musculature was recorded using the sit-and-reach test to the nearest half centimeter, using a specially designed box.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Flexibility in the shoulder joint at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Flexibility of the shoulder joint was registered to the nearest centimeter, using the back-scratch test.
The mean registered flexibility score of both shoulders was recorded.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Explosive power in the lower extremities at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Explosive power in the lower extremities was recorded to the nearest centimeter, using the vertical jump test.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Body mass index at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Body mass index was calculated using the formula weight/height^2.
Height and weight were measured using a measuring band (meters) and a weight scale (kilograms) respectively.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Waist circumference at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Waist circumference was registered using a measuring band and the mean of two measures was recorded to the nearest half-centimeter.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Fat percentage at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Fat percentage was measured using the bioimpedance machine InBody 720 and using skinfolds.
Both registered body fat percentage.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
|
Change from Baseline Cardiorespiratory fitness at 6 months
Ramy czasowe: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Cardiorespiratory fitness was measure by a modified Balke protocol on a treadmill and registered in l/min.
|
Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Age
Ramy czasowe: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
|
Age was assessed by questionaire to the nearest whole year.
|
This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
|
|
Gender
Ramy czasowe: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
|
Gender was assessed using a questionnaire and outcome was either Female or male.
|
This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
|
|
Educational level
Ramy czasowe: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
|
Educational level was assessed using a questionnaire as one of four different levels
|
This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Physical activity level
Ramy czasowe: This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
|
Physical activity level was assessed using IPAQ- sf as minutes of physical activity per week.
|
This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
|
|
Stage of change
Ramy czasowe: This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
|
Stage of change was assessed using a questionnaire as one of five alternatives.
|
This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Monica K Torstveit, PhD, University of Agder
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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 kwietnia 2011
Zakończenie podstawowe (Rzeczywisty)
1 października 2011
Ukończenie studiów (Rzeczywisty)
1 lutego 2012
Daty rejestracji na studia
Pierwszy przesłany
9 marca 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 maja 2017
Pierwszy wysłany (Rzeczywisty)
23 maja 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
25 maja 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 maja 2017
Ostatnia weryfikacja
1 maja 2017
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Aktiv i Sør
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Opis planu IPD
The IPD of the present study will be shared through publications (articles).
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
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
-
University of MichiganRejestracja na zaproszenieSmart-Quality Physical EducationStany Zjednoczone
Badania kliniczne na Intervention group - telephone and print exercise intervention
-
Aydin Adnan Menderes UniversityThe Scientific and Technological Research Council of TurkeyRekrutacyjnyMyśli samobójcze | Zapobieganie samobójstwom | Poradnictwo szkolneTurcja (Türkiye)
-
Sarah Wragge WellnessZakończonySyndrom metabliczny | Otyłość i nadwaga | Zapobieganie cukrzycy typu 2 | Monitorowanie poziomu glukozy we krwiStany Zjednoczone
-
Universidade do PortoRekrutacyjnyPo porodzie | Czynniki kardiometaboliczne | Remodelowanie odwrotnej sercaPortugalia
-
Uludag UniversityZakończony