跳至主要内容
临床试验/NCT05351177
NCT05351177Unknown不适用

The Feasibility of an 8-Week High-Intensity Interval Training (HIIT) or Concurrent Training (CT) Programme in Overweight and Obese Adult Males

University of Sunderland2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
试验地点
2
主要终点
Adherence

研究概览

简要总结

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.

详细描述

This study will incorporate a randomised controlled design, involving three distinct phases for two separate groups of participants. Participants will be randomly assigned into one of four groups via a computerised randomiser (Sealed Envelope Ltd., 2020), with a 1:1 allocation ratio using block sizes of two. These groups will consist of a HIIT group and concurrent training group. Three phases will be spread across 10 weeks for each participant:

  • Phase 1: baseline testing for all groups (week 1)
  • Phase 2: an 8-week exercise intervention for three experimental groups (weeks 2 - 9)
  • Phase 3: post-intervention testing for all groups (week 10). Participants will be provided with all of the study information and given the opportunity to ask questions from the researchers before providing informed consent. Full pre-exercise screening in accordance with the American College of Sports Medicine (ACSM) guidelines for exercise testing will be conducted. All participants will be overweight or obese (BMI > 25 kg.m2) and sedentary but will be excluded if pre-exercise screening highlights any other cardiovascular disease risk factor.

Phase One: Baseline Testing Once included in the study, participants will be randomised into one of two groups (HIIT or Concurrent). Both groups will perform exactly the same baseline testing procedures over the course of two days during Week 1 of the study duration. On the first day participants will arrive at the University of Sunderland exercise testing laboratory having completed a 12 hr fast, having abstained from caffeine and alcohol consumption for 24 hr and not exercised in the previous 72 hrs, and asked to consume 500 ml of water 1 hour prior to arrival.

Fasted blood samples will then be collected. Plasma glucose, lipid profile and HbA1C concentrations will be assessed via a fingertip capillary blood sample. Each fingertip capillary sample will be performed using a safety lancet. Blood samples will be immediately analysed and disposed of in clinical waste. Samples will be analysed via a CardioChek PA portable lipid analyser, HemoCue Hb analyser and Biosen blood glucose analyser. Once sterilised with an alcohol wipe, skin perforations will only be made on the fingertips, and participants will be provided with adhesive dressings should they be requested. There will then be a short break (~30 minutes) in which participants will be provided with a light breakfast of toasted white bread (50 g) with strawberry jam (40 g), constituting a total of 75 g Carbohydrate. After consuming the breakfast participants will score their appetite via a visual analogue scale (Flint et al., 2000). The breakfast will standardise pre-exercise nutritional status both between- and within-participants.

Pre-exercise health screening will be completed in line with American college of sports medicine (ACSM) and University of Sunderland guidelines. Inclusive of this screening procedure will be anthropometric measures (height, mass, waist and hip circumference) as well as resting heart rate (determined via a Polar heart rate monitor and wristwatch) and resting blood pressure (via automatic sphygmomanometer). Participants will be excluded upon evidence of any contraindications to exercise (ACSM, 2020). In addition to this, body fat will be determined via the BodyStat 1500 bioelectrical impedance device. This will not occur if the participant has any form of pacemaker device. Hydration status will be determined prior to bioelectrical impedance via an Osmocheck portable analyser.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 66 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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).

排除标准

  • 未提供

结局指标

主要结局

Adherence

时间窗: Throughout intervention (8 weeks)

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

Attendance

时间窗: Throughout Intervention (8 weeks)

Number of exercise training sessions attended.

In-Session Heart Rate

时间窗: Throughout intervention (8 weeks)

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

Enjoyment

时间窗: Throughout intervention (8 weeks)

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

Ratings of Perceived Exertion

时间窗: Throughout intervention (8 weeks)

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.

次要结局

  • Waist Circumference(Pre and Post (Weeks 1 and 10))
  • Hip Circumference(Pre and Post (Weeks 1 and 10))
  • Body Mass(Pre and Post (Weeks 1 and 10))
  • Height(Pre and Post (Weeks 1 and 10))
  • Body Fat(Pre and Post (Weeks 1 and 10))
  • Body Mass Index(Pre and Post (Weeks 1 and 10))
  • Left Ventricular Volume(Pre and Post (Weeks 1 and 10))
  • Left Ventricle(Pre and Post (Weeks 1 and 10))
  • Ejection Fraction(Pre and Post (Weeks 1 and 10))
  • Cholesterol(Pre and Post (Weeks 1 and 10))
  • VO2Peak(Pre and Post (Weeks 1 and 10))
  • High-Density-Lipoprotein Concentration(Pre and Post (Weeks 1 and 10))
  • Area Under the Glucose Curve(Pre and Post (Weeks 1 and 10))
  • Fasting Plasma Glucose(Pre and Post (Weeks 1 and 10))
  • Low-Density-Lipoprotein Concentration(Pre and Post (Weeks 1 and 10))
  • Triglycerides(Pre and Post (Weeks 1 and 10))
  • HbA1C(Pre and Post (Weeks 1 and 10))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Bell

PhD Researcher

University of Sunderland

研究点 (2)

Loading locations...

相似试验