- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Birmingham, Verenigd Koninkrijk, B15 2TT
- University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in body composition (fat and fat-free mass in kg)
Tijdsspanne: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Perceived body shape
Tijdsspanne: 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
Tijdsspanne: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Fat oxidation rates
Tijdsspanne: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Body tone
Tijdsspanne: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Blood-borne markers of metabolic health
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Bham_CPW_PhysActIntervention
Informatie over medicijnen en apparaten, studiedocumenten
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