Condition category
Circulatory System
Date applied
07/06/2013
Date assigned
14/06/2013
Last edited
10/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical activity is known to convey a number of health benefits but many people are effectively inactive and thus at risk of coronary heart disease and other cardiovascular conditions. Currently, people with hypertension (high blood pressure), suspected hypertension, pre-hypertension or high-normal blood pressure can be referred by their general practitioners (GPs) for a programme of gym-based activity and we want to see if we can find ways of improving the effectiveness of these referrals. Our goal is to find the best possible combination of activities that will promote continued increases in people’s activity levels.

Who can participate?
The study aims to recruit about 2000 people aged 18-74 years with hypertension, suspected hypertension, pre-hypertension or high-normal blood pressure.

What does the study involve?
People will be invited to attend a 12-week programme of exercise either with a gym focus or a more sporting focus. Some people will also be invited to use a new web-based self-help tool that will help them plan and record their activities. Which intervention(s) a participant is allocated to will be decided by a process called ‘randomisation’, which is like a coin toss. At the end of the study, which will be a year after the person first goes on the exercise programme, we will compare the amount of activity people engage in and also look at indicators of their cardiovascular health like blood pressure and body mass index (BMI) to see which interventions produce the most beneficial changes.

What are the possible benefits and risks of participating?
Participants will get a supervised programme of activity that will help them improve their cardiovascular fitness. They will also get advice on how to build activity into their daily lives. There are few risks in taking part since your GP will have already decided that a programme of activity would be good for you. Trained exercise professionals will be on hand to ensure your safety throughout the exercise programme.

Where is the study run from?
The study is being run by the University of Surrey in GP practices in the Guildford and Waverly CCG area.

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in the autumn of 2013 and run until mid summer 2015.

Who is funding the study?
Funding has been provided by Sport England with in kind support from partners Surrey County Council, Active Surrey, Surrey Sports Park, Spring Street Surgery, Isostasy.

Who is the main contact?
Prof Chris Fife-Schaw
c.fife-schaw@surrey.ac.uk

Trial website

http://www.clininf.eu/projects/ght2000.html

Contact information

Type

Scientific

Primary contact

Prof Chris Fife-Schaw

ORCID ID

Contact details

School of Psychology
University of Surrey
Stag Hill
Guildford
GU2 7XH
United Kingdom
+44 (0)1483 686873
c.fife-schaw@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Guildford Hypertension 2000: randomised trial of exercise interventions to increase levels of physical and sporting activity

Acronym

GHT2000

Study hypothesis

To test the independent and synergistic efficacy of a 12-week sports oriented exercise referral intervention and a self-help web-based intervention intended to promote sustained and increased levels of physical activity over a period of 12 months. Do these interventions separately and in combination improve these indicators and do they improve them above that expected by existing gym-based GP referral alone?

Do these interventions improve other clinical indicators of cardiovascular health [e.g. body mass index (BMI), waist and hip measures, blood pressure and other measures that contribute to the QRisk2 risk indicator) above that expected by existing gym-based GP referral? Do these interventions increase participation in sporting activity over a period of 12 months?

Ethics approval

Bloomsbury NHS REC, 19/9/2013, ref: 13/LO/1170

Study design

Four-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Currently inactive 18-74 year old people with hypertension, suspected hypertension, pre-hypertension or high-normal blood pressure.

Intervention

1. The first intervention is a web-based behaviour change support tool, that allows users to easily find out about outlets for organised activity, form and store plans to carry out the activities and to form a log of what they have achieved. The tool provides educational material and easy access to existing health maintenance sites. The user can set up the site to give alerts when events relating to their preferred sports/activities are available and to provide prompts to log the activities that they have completed.
2. The second intervention is a 12-week sports oriented exercise programme intended as a direct substitute for existing gym-based GP exercise referral. As with the latter this will be supervised by qualified exercise specialists but participants are given a choice of entry-level sports to pursue. Sports offered will include squash, badminton (‘Badmintone’), netball (‘Netfit’), tennis, swimming, walking football, bowls, athletics (‘AthleFIT’), ‘Cardio Tennis’ and a new ‘Healthy Cycle Ride’.
3. The control will be standard care which is referral of a 12-week for gym-based exercise programme.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The interventions individually will be regarded as successful if they lead to an average increase in activity of 100 Metabolic Equivalents (MET) -minutes per week as measured by the IPAQ-S. This equates to engaging in an extra moderate intensity activity, say brisk walking (3.3 MET) for 30 minutes per week. The new interventions will be regarded as superior to the standard gym-based referral if they increase activity levels above those of the standard care gym-based exercise by 20 MET-minutes per week. Activity will be measured at baseline, 12 weeks, 6 months and 12 months.

Secondary outcome measures

1. We will assess changes in indicators relating to cardiovascular health including blood pressure, weight and waist and hip circumference at baseline, 6 weeks, 12 weeks and 12 month. In terms of blood pressure the interventions will be regarded as successful if they lead to an average decrease in blood pressure of 2.5mmHg. We will assess the proportion of the sample reducing their blood pressure by more than 10 mmHg and an intervention will be regarded as a success if more than 20% of the members of that study arm achieve a reduction greater than this.
2. The interventions will be deemed to have been successful in promoting sports participation if they increase sports related activity by 100 MET-minutes per week.

Overall trial start date

01/09/2013

Overall trial end date

01/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. The patient is aged 18 to 74 years at randomisation
2. The patient has been diagnosed as having hypertension, suspected hypertension and pre-hypertension
3. The patient is screened as being ‘less than active’ on the General Practice Physical Activity Questionnaire (GPPAQ)
4. The patient has access to the internet and an e-mail account
5. The patient is able to understand the Informed Consent Form (ICF), and understand study procedures
6. The patient has signed the ICF

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

1. The patient is pregnant
2. Inability to freely consent to take part in the study
3. Inability to understand the study materials
4. The patient is unable to access the internet/email
5. Current participation in another clinical trial relating to physical activity or exercise
6. Any condition that, in the GP’s opinion, compromises the subject’s ability to meet protocol requirements or to complete the study
7. The patient is referred out of the trial by the exercise professional on the grounds that the programme is, in their judgement, is likely to cause harm

Recruitment start date

01/09/2013

Recruitment end date

01/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

c/o Mike Chenery
Stag Hill
Guildford
GU2 7XH
United Kingdom
+44 (0)1483 686434
m.chenery@surrey.ac.uk

Sponsor type

University/education

Website

http://www.surrey.ac.uk/

Funders

Funder type

Government

Funder name

Sport England (UK) - (Get Healthy, Get in to Sport project no. 2012021353) with in kind support from partners Surrey County Council, Active Surrey, Surrey Sports Park, Spring Street Surgery, Isostasy

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25168762

Publication citations

  1. Protocol

    Fife-Schaw C, de Lusignan S, Wainwright J, Sprake H, Laver S, Heald V, Orton J, Prescott M, Carr H, O'Neill M, Comparing exercise interventions to increase persistence with physical exercise and sporting activity among people with hypertension or high normal blood pressure: study protocol for a randomised controlled trial., Trials, 2014, 15, 336, doi: 10.1186/1745-6215-15-336.

Additional files

Editorial Notes