Condition category
Not Applicable
Date applied
20/02/2018
Date assigned
05/03/2018
Last edited
23/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Loss of lean body mass and strength are key public health concerns. Aerobic physical activity as currently prescribed in guidelines is relatively ineffective for improving these outcomes. Resistance training however is known to improve both. 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 involving resistance training using either a structured or unstructured approach, or physical activity counselling, upon lean body mass and strength.

Who can participate?
Sedentary adults (not meeting physical activity recommendations) currently not taking any medication for cardiovascular (heart) disease

What does the study involve?
Participants are offered one of two pathways. Those choosing the fitness centre pathway are randomly allocated to one of two interventions: a structured exercise programme or free/unstructured exercise. Those choosing a non-fitness centre pathway are randomly allocated to either physical activity counselling (PAC), or to just participate in the measurement sessions. At the start of the study and after the interventions (48 weeks) participants have their lean body mass and strength assessed.

What are the possible benefits and risks of participating?
Participants benefit from being able to take part in either community fitness centre interventions or physical activity counselling for 48 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?
University of Greenwich (UK)

When is the study starting and how long is it expected to run for?
January 2013 to April 2015

Who is funding the study?
University of Greenwich (UK) and ukactive (UK)

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

Trial website

Contact information

Type

Public

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

CommunityFitnessCentreStudy

Study information

Scientific title

The effects of 48 week structured exercise, unstructured exercise, physical activity counselling, or measurement only control on strength and body composition in sedentary adults

Acronym

Study hypothesis

A structured exercise intervention will result in greater strength and body composition improvements compared with either unstructured exercise, physical activity counselling, or measurement only control.

Ethics approval

University of Greenwich, 10/07/2012, ref: UREC/11/12.5.6.11

Study design

Semi-randomised trial

Primary study design

Interventional

Secondary study design

Semi-randomised 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 adults. The interventions (I) included two fitness centre interventions and a physical activity counselling intervention both described below, and the comparator (C) was a measurement only control group. Outcomes (O) included body composition and strength.

A semi-randomised trial design was utilised. Participants were initially offered one of two pathways. Those choosing the fitness centre pathway were randomised to one of two interventions; a structured exercise programme (STRUC), or free/unstructured exercise (FREE). Those choosing a non-fitness centre pathway were randomised to either physical activity counselling (PAC), or to a measurement only control condition (CONT) including two health checks. Interventions were delivered over 48 weeks with measures at 0 (baseline) and 48 weeks.

STRUC had access to all fitness centre facilities and received an individualised and structured RT programme. 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.

FREE participants had access to all fitness centre facilities but received no structured programme. Exercise professionals met with FREE participants once each month to discuss progress.

PAC participants met exercise professionals once each month for counselling sessions structured around the model proposed by Haase et al. and delivered within the fitness centre location. PAC participants did not however have access to any fitness centre exercise facilities.

CONT participants acted as the comparator group, did not receive an intervention, and did not have access to any fitness centre exercise facilities. Whilst CONT did not receive an exercise intervention, they did receive two free health screens (pre and post measurement) over the duration of the study. Exercise professionals were instructed to have no contact with CONT participants other than to arrange data collection at 0 and 48 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Measured pre and post (48 weeks) intervention:
1. Body composition, including BF mass (kg), LBM (kg) and BF percentage (%), measured using bioelectrical-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 (48 weeks) intervention:
1. Maximal aerobic capacity (VO2max) predicted using the Modified Balke Protocol. Participants walked on a treadmill at between 3.6 and 5.6 kph, depending on ability, for 3 min. Following this, the gradient was increased by 1% each minute. Ratings of perceived exertions were recorded at 1 min intervals using the OMNI1–10 scale. Oxygen consumption and heart rate were continuously monitored via direct gaseous analysis (Fitmate Pro, COSMED, Italy). Predicted VO2max was 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 150 bpm.
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).
3. Total cholesterol (TC: the sum of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol) measured via finger-prick blood analysis (Cholestech LDX, Alere, UK)

Overall trial start date

01/01/2013

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sedentary, defined as currently not meeting the physical activity recommendations of the UK Chief Medical Officer
2. Taking no medication that might impact cardiovascular risk

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

2080

Participant exclusion criteria

1. Not classified as sedentary
2. Currently taking medication that might impact cardiovascular disease risk

Recruitment start date

01/08/2013

Recruitment end date

01/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Topnotch Health Club
Unit 2 Phoenix Square Wyncolls Rd
Colchester
CO4 9AS

Trial participating centre

ESPH
116 Lordship Lane
London
SE22 8HD

Trial participating centre

DC Leisure – Malden Centre
Blagdon Road
New Malden
KT3 4TA

Trial participating centre

DC Leisure - Harbourne
Lordswood Road Harborne
Birmingham
B17 9QS

Trial participating centre

The Shrewsbury Club
Sundorne Road
Shrewsbury
SY1 4RG

Trial participating centre

Life Leisure: Avondale
Heathbank Road Cheadle Heath
Stockport
SK3 0UP

Trial participating centre

Eze Fitness Redditch
17 Alcester Street
Redditch
B98 8AE

Trial participating centre

Airdrie Leisure Centre
Motherwell Street
Airdrie
ML6 7HU

Trial participating centre

The Essex Golf & Country Club
Earls Colne
Colchester
CO6 2NS

Trial participating centre

Chartham Park
Felcourt Road Felcourt
East Grinstead
RH19 2JT

Trial participating centre

Adam Nicholas Eze Fitness
E Service Road Raynesway Spondon
Derby
DE21 7BB

Trial participating centre

Richie Sundaram / Jermaine Ward
15 Thomas More Square
London
E1W 1YW

Trial participating centre

White Horse Leisure and Tennis Centre
Audlett Drive
Abingdon
OX14 3PJ

Trial participating centre

All Seasons Leisure Centre
PR7 1EX

Trial participating centre

Ravenscraig Regional Sports Facility
O'Donnell Way
Motherwell
ML1 2TZ

Trial participating centre

Leith Victoria Leisure Centre
Junction Place
Edinburgh
EH6 5JA

Trial participating centre

Nizels Golf & Country Club
Nizels Lane
Hildenborough
TN11 8NU

Trial participating centre

Pent Valley Leisure Centre
Tile Kiln Lane Cheriton
Folkestone
CT19 4PB

Trial participating centre

Fitness First
179a Tottenham Court Road
London
W1T 7PA

Trial participating centre

Eze Fitness Scarborough
Dunslow Road Eastfield Business Park
Scarborough
YO11 3UT

Trial participating centre

Pontefract Squash and Leisure Club
Stuart Road
Pontefract
WF8 4PQ

Trial participating centre

Fitness First
Aspects Leisure Park Kingswood
Bristol
BS15 9LA

Trial participating centre

DC Leisure
Penns Place
Petersfield
GU31 4EX

Trial participating centre

St James Leisure Centre
72 Waterdale
Doncaster
DN1 3BU

Sponsor information

Organisation

University of Greenwich

Sponsor details

University of Greenwich
Old Royal Naval College
Park Row
Greenwich
London
SE10 9LS
United Kingdom

Sponsor type

University/education

Website

compliance@gre.ac.uk

Organisation

ukactive

Sponsor details

26 28 Bedford Row
London
WC1R 4HE
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

University/education

Funder name

University of Greenwich

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

ukactive

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes