A randomised controlled trial to investigate the effect of regular moderate intensity exercise on plasma fibrinogen in people with type two diabetes: a pilot study

ISRCTN ISRCTN98564438
DOI https://doi.org/10.1186/ISRCTN98564438
Protocol serial number N0249142478
Sponsor Department of Health
Funders Taunton and Somerset Research and Development Consortium (UK), NHS R&D Support Funding (UK)
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
12/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rob Andrews
Scientific

University of Bristol
Department of Exercise and Health Sciences
Tyndall Avenue
Bristol
BS8 1TP
United Kingdom

Phone +44 (0)1823 344988
Email rob.andrews@bristol.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA randomised controlled trial to investigate the effect of regular moderate intensity exercise on plasma fibrinogen in people with type two diabetes: a pilot study
Study objectivesDoes moderate intensity exercise modify plasma fibrinogen levels in people with type two diabetes?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedType two diabetes
InterventionRandomised controlled trial
Intervention typeOther
Primary outcome measure(s)

1. Plasma fibrinogen
2. Plasminogen activator inhibitor-1 (PAI-1)

Key secondary outcome measure(s)

Not provided at time of registration

Completion date06/10/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexAll
Target sample size at registration80
Key inclusion criteria80 patients with type two diabetes
Key exclusion criteria1. Smokers
2. Taking drugs affecting clotting
3. Inability to exercise
Date of first enrolment01/06/2003
Date of final enrolment06/10/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Bristol
Bristol
BS8 1TP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

12/09/2016: No publications found, verifying study status with principal investigator.