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Aktiv i Sør: a Randomized Controlled Trial (AiS)

tiistai 23. toukokuuta 2017 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

111

Vaihe

  • Ei sovellettavissa

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

40 vuotta - 55 vuotta (Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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
Käyttäytyminen: Intervention group - telephone and print exercise intervention
Intervention has previously been described.
Ei väliintuloa: Control group
The control group (CG) were encouraged to continue previous lifestyle.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change from Baseline Cardiorespiratory fitness at 6 months
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Age
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Physical activity level
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Agder

Yhteistyökumppanit

Norwegian School of Sport Sciences

Tutkijat

  • Päätutkija: Monica K Torstveit, PhD, University of Agder

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 1. huhtikuuta 2011

Ensisijainen valmistuminen (Todellinen)

Lauantai 1. lokakuuta 2011

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. helmikuuta 2012

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 9. maaliskuuta 2017

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 19. toukokuuta 2017

Ensimmäinen Lähetetty (Todellinen)

Tiistai 23. toukokuuta 2017

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 25. toukokuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 23. toukokuuta 2017

Viimeksi vahvistettu

Maanantai 1. toukokuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • Aktiv i Sør

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

Ei

IPD-suunnitelman kuvaus

The IPD of the present study will be shared through publications (articles).

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Liikunta

Kliiniset tutkimukset Intervention group - telephone and print exercise intervention

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