- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05702840
EXerCise wEight Loss (EXCEL)
February 26, 2024 updated by: Stuart Gray, University of Glasgow
The Effects of a Home-based Resistance Training Programme on Body Composition and Muscle Function During Weight Loss in People With Overweight or Obesity: a Randomised Controlled Pilot Trial
The overall aim of this study is to investigate the effects of home-based resistance exercise programme on changes in body composition and strength during weight loss, in people living with obesity or overweight.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glasgow, United Kingdom
- Stuart Robert Gray
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Obesity or overweight (BMI ≥ 25kg/m2).
- Passing the Physical Activity Readiness Questionnaire (PAR-q+)
Exclusion Criteria:
- Currently take part in more than 1.5 hours of structured exercise per week.
- Having recently (<6 months) taken part in any resistance exercise training, taking any medications known to affect weight loss.
- Actively engaged in a weight loss programme, having lost more than 2kg weight in the last 6 months.
- Any other reason which would limit ability to perform the exercises and outcome measurements safely.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Resistance exercise training + weight loss group (RT+WL)
Participants (WL-RT) will be provided with a resistance exercise booklet containing instructions for exercises and links to demonstration videos.
A demonstration and explanation of the exercises will be given at the beginning of the intervention, alongside a discussion of the principles of the programme such as starting level and progression.
We will ask participants to perform the resistance exercises for 12-week period.
Participants will be asked to perform exercises 3 times a week (3 sets reaching the RPE scale between 8 - 10 out of 10 (4-6 out of 10 in the first week)) for the intervention period.
The exercises will include press-ups, band lateral raises, band seated low row, squat, lunge and calf raise.
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Doing resistance exercises as well as following the weight watchers weight loss programme for a 12-week period
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Experimental: Weight loss only group (WL)
All participants (WL and WL-RT) will be provided with vouchers to access the weight watchers weight loss programme for a 12-week period.
Weight Watchers is a commercially available programme and participants will set an initial goal to lose 5kg of body mass.
If 5kg weight loss is achieved then the participant can chose further weight loss goals, as long as it would result in a body mass in the weight watchers healthy weight range (https://www.weightwatchers.com/uk/weight-loss/programme/tools/healthy-weight-chart).This plan works on the basis of an individualised points plan that can then be used by the participant to select foods/meals to consume throughout the day.
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Only following the weight watchers weight loss programme for a 12-week period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in whole body lean mass
Time Frame: Change from baseline to 12 weeks
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whole body lean mass measured via bio-electrical impedance
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Change from baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in whole body fat mass
Time Frame: Change from baseline to 12 weeks
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whole body fat mass measured via bio-electrical impedance
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Change from baseline to 12 weeks
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Change in body mass
Time Frame: Change from baseline to 12 weeks
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body mass measured on scales
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Change from baseline to 12 weeks
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Change in vastus lateralis muscle thickness
Time Frame: Change from baseline to 12 weeks
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Muscle thickness of the vastus lateralis muscle measured via ultrasound
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Change from baseline to 12 weeks
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Change in knee extensor maximal isometric torque
Time Frame: Change from baseline to 12 weeks
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Knee extensor maximal isometric torque measured during a maximal voluntary contraction
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Change from baseline to 12 weeks
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Change in grip strength
Time Frame: Change from baseline to 12 weeks
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Grip strength measured with a hand held dynamometer
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Change from baseline to 12 weeks
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Change in functional physical abilities
Time Frame: Change from baseline to 12 weeks
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A 30-second sit-to-stand test measured functional abilities
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Change from baseline to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6.
- Wolfe RR. The underappreciated role of muscle in health and disease. Am J Clin Nutr. 2006 Sep;84(3):475-82. doi: 10.1093/ajcn/84.3.475.
- Pellegrini M, Cioffi I, Evangelista A, Ponzo V, Goitre I, Ciccone G, Ghigo E, Bo S. Effects of time-restricted feeding on body weight and metabolism. A systematic review and meta-analysis. Rev Endocr Metab Disord. 2020 Mar;21(1):17-33. doi: 10.1007/s11154-019-09524-w. Erratum In: Rev Endocr Metab Disord. 2020 Feb 18;:
- Upadhyay J, Farr O, Perakakis N, Ghaly W, Mantzoros C. Obesity as a Disease. Med Clin North Am. 2018 Jan;102(1):13-33. doi: 10.1016/j.mcna.2017.08.004. Epub 2017 Oct 21.
- An R, Ji M, Zhang S. Global warming and obesity: a systematic review. Obes Rev. 2018 Feb;19(2):150-163. doi: 10.1111/obr.12624. Epub 2017 Oct 4.
- James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.
- Siervo M, Montagnese C, Mathers JC, Soroka KR, Stephan BC, Wells JC. Sugar consumption and global prevalence of obesity and hypertension: an ecological analysis. Public Health Nutr. 2014 Mar;17(3):587-96. doi: 10.1017/S1368980013000141. Epub 2013 Feb 18.
- Ge L, Sadeghirad B, Ball GDC, da Costa BR, Hitchcock CL, Svendrovski A, Kiflen R, Quadri K, Kwon HY, Karamouzian M, Adams-Webber T, Ahmed W, Damanhoury S, Zeraatkar D, Nikolakopoulou A, Tsuyuki RT, Tian J, Yang K, Guyatt GH, Johnston BC. Comparison of dietary macronutrient patterns of 14 popular named dietary programmes for weight and cardiovascular risk factor reduction in adults: systematic review and network meta-analysis of randomised trials. BMJ. 2020 Apr 1;369:m696. doi: 10.1136/bmj.m696. Erratum In: BMJ. 2020 Aug 5;370:m3095.
- Cava E, Yeat NC, Mittendorfer B. Preserving Healthy Muscle during Weight Loss. Adv Nutr. 2017 May 15;8(3):511-519. doi: 10.3945/an.116.014506. Print 2017 May.
- Enriquez Guerrero A, San Mauro Martin I, Garicano Vilar E, Camina Martin MA. Effectiveness of an intermittent fasting diet versus continuous energy restriction on anthropometric measurements, body composition and lipid profile in overweight and obese adults: a meta-analysis. Eur J Clin Nutr. 2021 Jul;75(7):1024-1039. doi: 10.1038/s41430-020-00821-1. Epub 2020 Dec 9.
- Sajoux I, Lorenzo PM, Gomez-Arbelaez D, Zulet MA, Abete I, Castro AI, Baltar J, Portillo MP, Tinahones FJ, Martinez JA, Crujeiras AB, Casanueva FF. Effect of a Very-Low-Calorie Ketogenic Diet on Circulating Myokine Levels Compared with the Effect of Bariatric Surgery or a Low-Calorie Diet in Patients with Obesity. Nutrients. 2019 Oct 4;11(10):2368. doi: 10.3390/nu11102368.
- Ashton RE, Tew GA, Aning JJ, Gilbert SE, Lewis L, Saxton JM. Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis. Br J Sports Med. 2020 Mar;54(6):341-348. doi: 10.1136/bjsports-2017-098970. Epub 2018 Jun 22.
- Plotnikoff RC, Eves N, Jung M, Sigal RJ, Padwal R, Karunamuni N. Multicomponent, home-based resistance training for obese adults with type 2 diabetes: a randomized controlled trial. Int J Obes (Lond). 2010 Dec;34(12):1733-41. doi: 10.1038/ijo.2010.109. Epub 2010 Jun 8.
- Mikesky AE, Topp R, Wigglesworth JK, Harsha DM, Edwards JE. Efficacy of a home-based training program for older adults using elastic tubing. Eur J Appl Physiol Occup Physiol. 1994;69(4):316-20. doi: 10.1007/BF00392037.
- Zion AS, De Meersman R, Diamond BE, Bloomfield DM. A home-based resistance-training program using elastic bands for elderly patients with orthostatic hypotension. Clin Auton Res. 2003 Aug;13(4):286-92. doi: 10.1007/s10286-003-0117-3.
- NIH Consensus statement. Bioelectrical impedance analysis in body composition measurement. National Institutes of Health Technology Assessment Conference Statement. December 12-14, 1994. Nutrition. 1996 Nov-Dec;12(11-12):749-62.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
January 18, 2023
First Submitted That Met QC Criteria
January 18, 2023
First Posted (Actual)
January 27, 2023
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXerCise wEight Loss Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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