The effects of different community fitness centre based interventions in sedentary adults
| ISRCTN | ISRCTN13024854 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13024854 |
| Secondary identifying numbers | CommunityFitnessCentreStudy |
- Submission date
- 20/02/2018
- Registration date
- 05/03/2018
- Last edited
- 15/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Contact information
Public
Waters Edge
Building Nine, Riverside Way
Watchmoor Park
Camberley
GU15 3YL
United Kingdom
Scientific
26 28 Bedford Row
London
WC1R 4HE
United Kingdom
Study information
| Study design | Semi-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Semi-randomised trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| 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(s) | University of Greenwich, 10/07/2012, ref: UREC/11/12.5.6.11 |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2013 |
| Overall study end date | 01/04/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2080 |
| 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 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
- England
- Scotland
- United Kingdom
Study participating centres
Phoenix Square
Wyncolls Rd
Colchester
CO4 9AS
United Kingdom
London
SE22 8HD
United Kingdom
New Malden
KT3 4TA
United Kingdom
Harborne
Birmingham
B17 9QS
United Kingdom
Shrewsbury
SY1 4RG
United Kingdom
Cheadle Heath
Stockport
SK3 0UP
United Kingdom
Redditch
B98 8AE
United Kingdom
Airdrie
ML6 7HU
United Kingdom
Colchester
CO6 2NS
United Kingdom
Felcourt
East Grinstead
RH19 2JT
United Kingdom
Raynesway Spondon
Derby
DE21 7BB
United Kingdom
London
E1W 1YW
United Kingdom
Abingdon
OX14 3PJ
United Kingdom
United Kingdom
Motherwell
ML1 2TZ
United Kingdom
Edinburgh
EH6 5JA
United Kingdom
Hildenborough
TN11 8NU
United Kingdom
Cheriton
Folkestone
CT19 4PB
United Kingdom
London
W1T 7PA
United Kingdom
Eastfield Business Park
Scarborough
YO11 3UT
United Kingdom
Pontefract
WF8 4PQ
United Kingdom
Kingswood
Bristol
BS15 9LA
United Kingdom
Petersfield
GU31 4EX
United Kingdom
Doncaster
DN1 3BU
United Kingdom
Sponsor information
University/education
University of Greenwich
Old Royal Naval College
Park Row
Greenwich
London
SE10 9LS
England
United Kingdom
| Website | compliance@gre.ac.uk |
|---|
Industry
26 28 Bedford Row
London
WC1R 4HE
United Kingdom
Not defined
| Website | http://www2.gre.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00bmj0a71 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 23/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in BMC Public Health. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/03/2018 | Yes | No |
Editorial Notes
15/02/2019: Publication reference added.
