Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/10/2007
Date assigned
23/01/2008
Last edited
27/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nick Wareham

ORCID ID

Contact details

Medical Research Council Epidemiology Unit
Institute of Metabolic Science
BOX 285
Hills Road
Cambridge
CB2 0QQ
United Kingdom

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

http://www.mrc-epid.cam.ac.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes