NCT05351177

Brief Summary

Overweight and obesity is becoming increasingly prevalent, constituting 64% of all adults in England, causing an incessant rise in cost to the National Health Service. Exercise and physical activity have the potential to reduce incidence of overweight and obesity, as well as improve obesity-related ill health. However, overweight and obese individuals are inherently sedentary and do not meet exercise guidelines. Same-session concurrent exercise training may be the most efficient exercise strategy to incorporate both cardiovascular- and strength-based exercise, both of which are vital for health-related benefits. This research project will aim to determine the feasibility of completing an 8-week concurrent exercise training programme in overweight and obese sedentary males. This study will aim to recruit adult males with a BMI above 25 kg.m2, who are otherwise healthy, but not regularly achieving exercise guidelines (less than 150 minutes of physical activity and 2 strength training sessions per week). Participants will undergo baseline and post-training testing of cardiorespiratory fitness, strength, heart and metabolic health, as well as a series of questionnaires and a semi-structured interview. They will then be randomised into one of two groups (high-intensity interval training or concurrent training) to complete twice-weekly exercise sessions for 8 weeks. The aims of this study are to evaluate the feasibility of performing 8-weeks of either concurrent, resistance or high-intensity interval training in overweight and obese males. This will be determined through assessment of cardiorespiratory fitness, strength, heart health, metabolic health, enjoyment, adherence and attendance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 8, 2022

Last Update Submit

April 22, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Adherence

    Feasibility of the study will be measured via adherence to the exercise programme (number of intervals of HIIT or repetitions of resistance exercises completed).

    Throughout intervention (8 weeks)

  • Attendance

    Number of exercise training sessions attended.

    Throughout Intervention (8 weeks)

  • Enjoyment

    Scores will be taken from the Physical Activity Enjoyment Scale (PACES), which will be completed at the end of each exercise session.

    Throughout intervention (8 weeks)

  • In-Session Heart Rate

    The heart rate (in beats per minute) at the end of each HIIT interval or set of resistance exercise measured via Polar Wristwatch.

    Throughout intervention (8 weeks)

  • Ratings of Perceived Exertion

    The Rating of Perceived Exertion (RPE) at the end of each HIIT interval or resistance exercise, provided by each participant on the Borg category-ratio 100 scale, expressed in arbitrary units.

    Throughout intervention (8 weeks)

Secondary Outcomes (17)

  • Body Mass

    Pre and Post (Weeks 1 and 10)

  • Height

    Pre and Post (Weeks 1 and 10)

  • Waist Circumference

    Pre and Post (Weeks 1 and 10)

  • Hip Circumference

    Pre and Post (Weeks 1 and 10)

  • Body Fat

    Pre and Post (Weeks 1 and 10)

  • +12 more secondary outcomes

Study Arms (2)

High-Intensity Interval Training Group

EXPERIMENTAL

Participants in the High-Intensity Interval Training (HIIT) group will complete 8 weeks of twice-weekly HIIT of 30 minutes in duration. Heart rate, ratings of perceived exertion, affect and enjoyment will be assessed. This will include a five minute warm-up on a cycle ergometer, followed by 10 x 60 second repetitions on the cycle ergometer interspersed with 60 seconds rest. A five minute cooldown will follow on the cycle ergometer.

Other: Exercise Training

Concurrent Training Group

EXPERIMENTAL

Participants in the Concurrent Training (CT) group will complete 8 weeks of twice-weekly CT of 30 minutes in duration. Heart rate, ratings of perceived exertion, affect and enjoyment will be assessed. This will include a five minute warm-up on a cycle ergometer, followed by two sets of four then eight repetitions of deadlift, squat, bench press and shoulder press resistance exercises. Thereafter, 5 x 60 second HIIT cycling intervals will be completed on a cycle ergometer, after which a five minute cooldown will ensue.

Other: Exercise Training

Interventions

Either of; 8-weeks twice-weekly High-Intensity Interval Training or Same-Session Concurrent Exercise Training.

Concurrent Training GroupHigh-Intensity Interval Training Group

Eligibility Criteria

Age18 Years - 66 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult males (18 - 66 years)
  • Overweight or obese ( \>25 kg.m2 body mass index - BMI)
  • Normally achieve less than 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity physical activity and 2 strength training sessions per week
  • No existing comorbidities (e.g. type 2 diabetes mellitus, hypertension)
  • Have not completed an exercise training programme in the previous 3 months
  • Are not currently completing a weight loss intervention (e.g. pharmacological/dietary)
  • No existing musculoskeletal injury
  • Have not tested positive for COVID-19 within the previous 6 months and are asymptomatic from COVID-19 related symptoms.
  • Have adverse or allergic reactions to the allergens present in white bread or strawberry jam (e.g. Gluten).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sunderland

Sunderland, Tyne and Wear, SR1 3SD, United Kingdom

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 28, 2022

Study Start

October 1, 2021

Primary Completion

June 1, 2022

Study Completion

January 1, 2023

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations