- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03164239
Aktiv i Sør: a Randomized Controlled Trial (AiS)
23. Mai 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
111
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Kein Eingriff: Control group
The control group (CG) were encouraged to continue previous lifestyle.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change from Baseline Cardiorespiratory fitness at 6 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Age
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Physical activity level
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Monica K Torstveit, PhD, University of Agder
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2011
Primärer Abschluss (Tatsächlich)
1. Oktober 2011
Studienabschluss (Tatsächlich)
1. Februar 2012
Studienanmeldedaten
Zuerst eingereicht
9. März 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Mai 2017
Zuerst gepostet (Tatsächlich)
23. Mai 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Mai 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. Mai 2017
Zuletzt verifiziert
1. Mai 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- Aktiv i Sør
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Beschreibung des IPD-Plans
The IPD of the present study will be shared through publications (articles).
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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