Back to resultsEXerCise wEight Loss (EXCEL)
Primary Purpose
Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Resistance exercise training + weight loss group
Weight loss only group (WL)
Sponsored by
About this trial
This is an interventional basic science trial for Overweight and Obesity
Eligibility Criteria
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.
Sites / Locations
- Stuart Robert GrayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Resistance exercise training + weight loss group (RT+WL)
Weight loss only group (WL)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in whole body lean mass
whole body lean mass measured via bio-electrical impedance
Secondary Outcome Measures
Change in whole body fat mass
whole body fat mass measured via bio-electrical impedance
Change in body mass
body mass measured on scales
Change in vastus lateralis muscle thickness
Muscle thickness of the vastus lateralis muscle measured via ultrasound
Change in knee extensor maximal isometric torque
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
Change in grip strength
Grip strength measured with a hand held dynamometer
Change in functional physical abilities
A 30-second sit-to-stand test measured functional abilities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05702840
Brief Title
EXerCise wEight Loss
Acronym
EXCEL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled pilot trial with two groups, resistance exercise + weight loss group and weight loss only group.
Masking
Outcomes Assessor
Masking Description
Members of the research team that perform measurements are blinded to group allocation.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Resistance exercise training + weight loss group (RT+WL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Weight loss only group (WL)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise training + weight loss group
Intervention Description
Doing resistance exercises as well as following the weight watchers weight loss programme for a 12-week period
Intervention Type
Behavioral
Intervention Name(s)
Weight loss only group (WL)
Intervention Description
Only following the weight watchers weight loss programme for a 12-week period
Primary Outcome Measure Information:
Title
Change in whole body lean mass
Description
whole body lean mass measured via bio-electrical impedance
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in whole body fat mass
Description
whole body fat mass measured via bio-electrical impedance
Time Frame
Change from baseline to 12 weeks
Title
Change in body mass
Description
body mass measured on scales
Time Frame
Change from baseline to 12 weeks
Title
Change in vastus lateralis muscle thickness
Description
Muscle thickness of the vastus lateralis muscle measured via ultrasound
Time Frame
Change from baseline to 12 weeks
Title
Change in knee extensor maximal isometric torque
Description
Knee extensor maximal isometric torque measured during a maximal voluntary contraction
Time Frame
Change from baseline to 12 weeks
Title
Change in grip strength
Description
Grip strength measured with a hand held dynamometer
Time Frame
Change from baseline to 12 weeks
Title
Change in functional physical abilities
Description
A 30-second sit-to-stand test measured functional abilities
Time Frame
Change from baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart R Gray, PhD
Phone
01413302569
Ext
Gray
Email
stuart.gray@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad S Binmahfoz, MSc
Email
a.binmahfoz.1@research.gla.ac.uk
Facility Information:
Facility Name
Stuart Robert Gray
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart R Gray
Phone
01413302569
Email
stuart.gray@glasgow.ac.uk
Phone
01413302569
Ext
Gray
Email
stuart.gray@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Stuart R Gray, PhD
12. IPD Sharing Statement
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EXerCise wEight Loss
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