Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to determine whether differential responses to a physical activity training programme are seen between individuals with low birth weight compared to individuals with a normal birth weight.
More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?RecType=Unit&AgreementId=88572&CaseId=21340
Ethics approval
Ethics approval received from the Hertfordshire Local Research Ethics Committee on the 23rd May 2005 (ref: 05/Q0201/23).
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Metabolic risk
Intervention
Aerobic exercise programme versus care as usual. The control group continue with their normal activities. The exercise group take part in a fully supervised 12- week aerobic exercise programme. There are three sessions each week and each one lasts sixty minutes.
Contact for queries:
Miss Jessica Horton
Email: Jessica.Horton@mrc-epid.cam.ac.uk
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Clustered Metabolic Risk Score.
Study participants return for their second visit thirteen weeks after their baseline visit. The outcomes will be measured at this time.
Secondary outcome measures
1. Body composition
2. Insulin sensitivity
3. Physical fitness
Study participants return for their second visit thirteen weeks after their baseline visit. The outcomes will be measured at this time.
Overall trial start date
17/01/2007
Overall trial end date
01/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy volunteers from the Hertfordshire Birth Cohort
2. Male and female, born between 1931 - 1939
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Diabetes
2. Untreated hypertension
3. Ischaemic heart disease
Recruitment start date
17/01/2007
Recruitment end date
01/03/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Research Council Epidemiology Unit
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Medical Research Council Epidemiology Unit (UK)
Sponsor details
Institute of Metabolic Science
BOX 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council Epidemiology Unit (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19545359
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20052455
Publication citations
-
Protocol
Finucane FM, Horton J, Purslow LR, Savage DB, Brage S, Besson H, Horton K, Rolfe Ede L, Sleigh A, Sharp SJ, Martin HJ, Sayer AA, Cooper C, Ekelund U, Griffin SJ, Wareham NJ, Randomized controlled trial of the efficacy of aerobic exercise in reducing metabolic risk in healthy older people: The Hertfordshire Physical Activity Trial., BMC Endocr Disord, 2009, 9, 15, doi: 10.1186/1472-6823-9-15.
-
Results
Finucane FM, Sharp SJ, Purslow LR, Horton K, Horton J, Savage DB, Brage S, Besson H, De Lucia Rolfe E, Sleigh A, Martin HJ, Aihie Sayer A, Cooper C, Ekelund U, Griffin SJ, Wareham NJ, The effects of aerobic exercise on metabolic risk, insulin sensitivity and intrahepatic lipid in healthy older people from the Hertfordshire Cohort Study: a randomised controlled trial., Diabetologia, 2010, 53, 4, 624-631, doi: 10.1007/s00125-009-1641-z.