Condition category
Not Applicable
Date applied
20/02/2018
Date assigned
06/03/2018
Last edited
28/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Resistance training is effective at modifying risk factors for metabolic disease. However, there is relatively little research examining community-based resistance training interventions for public health. The aim of this study is to examine the effects of community fitness centre based exercise interventions, delivered through a GP referral scheme, involving resistance training compared with physical activity counselling or a combination of both, upon lean body mass and strength.

Who can participate?
Adults who are overweight or obese, and/or deemed to be at increased risk of type 2 diabetes by their GP, who are not currently taking prescribed medications for any cardiovascular or metabolic conditions

What does the study involve?
Participants enter an exercise referral scheme and are randomly allocated to either a structured exercise program involving resistance training, physical activity counselling, a combination of the two, or a waiting list. Those allocated to the waiting list are randomly allocated to one of the interventions upon completion of the waiting period. At the start of the study and after the interventions (48 weeks) participants have their lean body mass and strength measured.

What are the possible benefits and risks of participating?
Participants benefit from being able to take part in structured exercise interventions or physical activity counselling for 12 weeks, which may result in improvements in lean body mass and strength. The potential risks include injury or other complications as a result of the exercise program.

Where is the study run from?
London Borough of Bexley (UK)

When is the study starting and how long is it expected to run for?
October 2014 to February 2016

Who is funding the study?
Parkwood Leisure and The London Borough of Bexley (UK)

Who is the main contact?
1. Dr Steven Mann (scientific)
2. Dr James Steele (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steven Mann

ORCID ID

Contact details

Waters Edge
Building Nine
Riverside Way
Watchmoor Park
Camberley
GU15 3YL
United Kingdom

Type

Scientific

Additional contact

Dr James Steele

ORCID ID

Contact details

26 28 Bedford Row
London
WC1R 4HE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ParkwoodTrial

Study information

Scientific title

The effects of structured exercise, physical activity counselling, or a combination of both, upon strength and body composition in overweight and obese adults taking part in an exercise referral scheme

Acronym

Study hypothesis

Interventions including structured exercise will result in greater strength and body composition compared with physical activity counselling, or measurement only control.

Ethics approval

National Health Service Research Ethics Committee, London - Queen Square Research Ethics Committee, UK, 01/12/2014, IRAS project ID 172321, REC ref: 15/LO/0540

Study design

Randomised wait-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

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

Condition

Physical activity and exercise

Intervention

The population (P) was sedentary overweight or obese adults with, or at increased risk of, Type 2 Diabetes. The interventions (I) included three interventions groups described in detail below; a general practitioner (GP) exercise referral scheme of structured exercise (STRUC), physical activity counselling (PAC), or a combination of both (COMB). The comparator (C) was a wait-list control group awaiting entry into the GP exercise referral scheme. Outcomes (O) included body composition and strength.

Participants were randomly assigned to one of four groups including the three intervention groups and one wait-list control group. All interventions were delivered over a period of 12 weeks.

STRUC received one session per week of a structured and supervised GP exercise referral intervention. This intervention was already delivered as part of the care pathway of the local health trust and participants were restricted to these sessions. This programme was based on guidelines published by the American College of Sports Medicine (ACSM). RT loads were based upon calculations of one-repetition maximum (1RM) derived from baseline data (see below). As the studies were conducted in ecologically valid community settings there was some flexibility in the exercises utilised based on participant preferences and any orthopaedic issues/injuries. However, all participants at a minimum followed a full body routine consisting of an upper body multi-joint push (e.g. chest press, overhead press, or dip), upper body multi-joint pull (e.g. pulldown, or seated row), and lower body multi-joint push (e.g. leg press). Exercise professionals met STRUC participants once a month to discuss their progress.

PAC received one session per week of physical activity counselling. The sessions were structured around the model proposed by Haase et al. and no access to fitness facilities.

COMB received a combination of physical activity counselling (sessions in weeks 1, 3, 5, 7, 9 & 11) and a structured and supervised GP exercise referral intervention (sessions in weeks 2, 4, 6, 8, 10 & 12).

The CONT group was formed from a wait-list control facilitated by a legitimate 12-week waiting list for entry into the GP exercise referral intervention. CONT participants received the intervention after this period, though only their waiting list period data was included for analysis.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured pre and post (12 weeks) intervention:
1. Body composition, including BF mass (kg), lean mass (kg) and BF percentage (%), measured using bio-impedance (Bodystat 1500, Bodystat, Isle of Man, UK). Guidelines from the National Institute of Health Research Southampton Biomedical Research Centre were followed for body compositions assessment (http://www.uhs.nhs.uk/Media/Southampton-Clinical-Research/Procedures/BRCProcedures/Procedure-for-bioimpedance-with-Bodystat-1500.pdf)
2. Predicted 1RM for chest press, pull down and leg press, obtained by gauging the maximal weight that could be lifted successfully for between 5 and 15 repetitions, and inputting these data into the Brzycki equation (i.e. weight/(1.0278-(0.0278 x No. Repetitions)). These results were collapsed into a single strength measure (the mean of the predicted 1RM for each exercise)

Secondary outcome measures

Measured pre and post (12 weeks) intervention:
1. Maximal aerobic capacity (VO2max) predicted using the Modified Balke Protocol. Participants walked on a treadmill at between 3.6 and 5.6kph, depending on ability, for 3 min. Following this, the gradient was increased by 1% each minute. Ratings of perceived exertions recorded at 1-min intervals using the OMNI1–10 scale. Oxygen consumption and heart rate continuously monitored via direct gaseous analysis (Fitmate Pro, COSMED, Italy). Predicted VO2max automatically extrapolated using the relationship with heart rate. The test was terminated when participants indicated perceived exertion above six (hard) and/or their heart rate reached 150bpm
2. Mean arterial pressure (MAP), which describes the average arterial pressure during a single cardiac cycle, incorporating both systolic and diastolic phases, but weighted towards the diastolic. Systolic (SBP) and diastolic (DBP) blood pressures (mmHg) were measured using a commercially available blood pressure monitor (Omron Healthcare, Japan). Three readings were collected and the mean value reported. MAP was estimated via the calculation MAP=DBP+0.33(SBP−DBP)

Overall trial start date

01/10/2014

Overall trial end date

01/02/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Overweight and/or obese (BMI 25-35), and/or at increased risk of type 2 diabetes as determined by their General Practitioner (GP)
2. Not currently taking any prescribed medication for cardiovascular or metabolic conditions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Not classified as overweight or obese
2. Not deemed to be at increased risk of Type 2 diabetes as determined by their General Practitioner (GP)
3. Currently taking prescribed medication for cardiovascular or metabolic conditions

Recruitment start date

01/01/2015

Recruitment end date

01/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Crook Log Leisure Centre
Brampton Road
Bexleyheath
DA7 4HH

Sponsor information

Organisation

ukactive

Sponsor details

26 28 Bedford Row
London
WC1R 4HE
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Parkwood Leisure

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

London Borough of Bexley

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in BMC Public Health.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Steven Mann or Dr James Steele.

Intention to publish date

23/05/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes