| Source of record | UK Trials |
| ISRCTN | ISRCTN60986572 |
| Date ISRCTN assigned | 23/01/2008 |
| Local reference number(s) | N/A |
| Public title | The Hertfordshire Physical Activity Trial |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Metabolic risk |
| 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. |
| Design/methodology | Interventional, randomised, controlled, single-centre trial |
| Research ethics review | Ethics approval received from the Hertfordshire Local Research Ethics Committee on the 23rd May 2005 (ref: 05/Q0201/23). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Healthy volunteers from the Hertfordshire Birth Cohort.
2. Male and female, born between 1931 - 1939 |
| Participants - exclusion criteria | 1. Diabetes
2. Untreated hypertension
3. Ischaemic heart disease |
| Patient information material |
|
| Anticipated start date | 17/01/2007 |
| Anticipated end date | 01/03/2008 |
| Status of trial | Completed |
| Target number of participants | 100 |
| Interventions | 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 |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | Medical Research Council Epidemiology Unit (UK) |
| Sponsor name | Medical Research Council Epidemiology Unit (UK) |
| Sponsor details | Institute of Metabolic Science
BOX 285
Addenbrooke's Hospital
Hills Road
Cambridge
United Kingdom
CB2 0QQ |
| Sponsor website | http://www.mrc-epid.cam.ac.uk/ |
| Contact name | Prof Nick Wareham |
| Contact details | Medical Research Council Epidemiology Unit
Institute of Metabolic Science
BOX 285
Hills Road
Cambridge
United Kingdom
CB2 0QQ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN60986572 |
| Date last extracted from ISRCTN register | 17/04/2008 |
