- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02020239
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
The investigators goal is to optimise physical activity interventions to help previously inactive women improve their body shape and composition. Many people seeking to lose weight or improve body composition initiate an exercise programme. The most common recommendation of an exercise intervention for someone attempting to manage their weight, has been to 'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation), often using one mode of exercise. An alternative approach might be to offer a portfolio of activities, from which the exerciser can pick and choose, to facilitate greater amounts of physical activity. The problem with this is how do you account for the different intensities of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the investigators will try to overcome this barrier by allocating a number of "physical activity points" to each activity. Using this physical activity points system, participants will be provided with a points target that they can meet using any combination of activities.
The investigators research aim is therefore to compare this points-based system against the traditional 5x30minute prescription (and sedentary control) for their ability to help previously inactive women to drop a dress size, increase fat burning, positively change their body composition and tone their tummy.
Studienübersicht
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Birmingham, Vereinigtes Königreich, B15 2TT
- University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Female
- Aged 25-50 years old
- Inactive (less than 150 minutes of moderate-intensity aerobic physical activity per week)
- BMI 25-35 kg/m2
- Good general health, as assessed by the School of Sport, Exercise and Rehabilitation Sciences' General Health Questionnaire
- Willing to strictly comply with all study procedures and restrictions
- Willing to participate, as demonstrated by voluntary written informed consent
Exclusion Criteria:
- Positive result from the urine sample pregnancy test
- Currently breast feeding
- Currently participating in another clinical trial deemed to potentially interfere with this study
- Current or recent (within the last 30 days) smoker
- Currently taking prescription or non-prescription medication that may interfere with metabolism (including beta-blockers, insulin, bronchodilators, anti-inflammatory agents, thyroxine and medication/supplements that in the opinion of the investigators may affect metabolism).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Prescribed exercise
Participants will be asked to choose one activity and stick to it for the duration of the intervention.
Participants will be able to choose between brisk walking/slow jogging or cycling.
The intervention will require the completion of 30 minutes of chosen activity on 5 days of the week, which will be recorded in a physical activity diary.
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Experimental: Points-based physical activity
Participants will be asked to achieve a pre-set, individualised points target for physical activity each week.
Points are acquired through the completion of a minimum 10 minutes of activity, choosing from the extensive list of activities provided; for example, 10 minutes of jogging achieves 4.5 points, whereas 10 minutes of washing a car achieves 1.5 points.
The target will be 35-40 points per week, which equates to approximately 6 points per day.
Any combination of activity, duration and frequency can be selected.
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Kein Eingriff: Waiting list control
Participants will be asked to maintain their normal activities and diet.
They will be added to a waiting list to receive either exercise intervention after completing the 24-week trial period, so that they do not miss out on the opportunity to receive the exercise intervention.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Change in body composition (fat and fat-free mass in kg)
Zeitfenster: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Perceived body shape
Zeitfenster: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Maximal aerobic capacity
Zeitfenster: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Fat oxidation rates
Zeitfenster: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Body tone
Zeitfenster: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Blood-borne markers of metabolic health
Zeitfenster: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Psychological measures relating to perceived body image
Zeitfenster: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Psychological measures of attitudes towards exercise and physical activity
Zeitfenster: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Bham_CPW_PhysActIntervention
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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