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临床试验/NCT05934760
NCT05934760已完成不适用

Assessing the Impact of Age, and a Short-term High-intensity Interval Training (HIIT) on Skeletal Muscle Mass and Mitochondrial Activity

University of Nottingham2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Mitochondrial activity change with a short-term home-based exercise program in older participants

研究概览

简要总结

The goal of this interventional study is to learn about the role of mitochondrial function in healthy aging, and then go on and assess the role of a home-based exercise program on the changes seen. The main question[s] it aims to answer are:

  • What alterations in skeletal muscle mitochondrial function are seen in healthy aging?
  • Can a short-term exercise program alter these alterations seen?

The older participants will be invited to take part in a home-based 4 week exercise intervention involving either:

  • High intensity interval training
  • Resistance based training (resistance bands will be provided) Researchers will compare the two exercise groups to see if it alters mitochondrial function.

详细描述

The study will aim to recruit 40 healthy male and female volunteers. They will be assigned into one of three groups;

  1. 18 - 35 years old (n=12, 6M:6F)
  2. 40 - 55 years old (n=12, 6M:6F)
  3. Greater than 65 years old (n=16, 8F:8M)

All volunteers will undergo a full consenting process and undergo a full screening to ensure eligibility prior to commencing the study. If eligible for inclusion in the study, the time commitment will vary from a single half-day study visit, to 12 training sessions over a 4-week period (3 sessions per week) and two half-day study visits (one before and one after the training sessions) depending on the participant's age.

All participants will attend fasted from 22:00 the previous day. Participants will first have a single muscle biopsy of the vastus lateralis before a dual-energy x-ray absorptiometry (DXA) scan to assess body composition and an ultrasound scan of the thigh to assess the muscle structure. A supervised cardiopulmonary exercise testing (CPET) to determine cardiorespiratory fitness will then be performed before a battery of physical function assessments to determine muscle and neuromuscular function. The biopsies will be assessed using an OROBOROS respirometer for the primary endpoint of mitochondrial activity, as well being used to determine cell signaling activity and gene expression.

For those under 65 years of age, a follow-up visit 4-6 days after the biopsy for stitch removal and to complete an end of study questionnaire would be the end of the study. Those volunteers over the age of 65 years will be randomly allocated to a RET group or HIIT group for a 4-week period, after which the assessments from the baseline study day would be repeated. Each exercise group will contain 8 participants (4 male, 4 female).

研究设计

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

盲法说明

Due to the nature of exercise interventions, it is not possible to blind the participants or investigators.

入排标准

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

入选标准

  • ● Healthy male or female aged over 18 years old able to give informed, written consent.

排除标准

  • ● Current participation in a formal exercise regime
  • Inability to use a static exercise bike
  • A BMI <18 or >35 kg/m2
  • Active cardiovascular disease:
  • Uncontrolled hypertension (BP > 160/100)
  • Heart failure (class III/IV)
  • Significant arrhythmia
  • Right to left cardiac shunt
  • Recent cardiac event
  • Taking beta-adrenergic blocking agents
  • Cerebrovascular disease:
  • Previous stroke
  • Aneurysm (large vessel or intracranial)
  • Respiratory disease including:
  • Pulmonary hypertension
  • Significant COPD
  • Uncontrolled asthma
  • Malignancy
  • Clotting dysfunction
  • Significant musculoskeletal or neurological disorders
  • Any suspected or confirmed diagnosis of Covid-19

研究组 & 干预措施

High intensity interval training (HIIT)

Experimental

Older participants (over 60) will be randomized to perform home-based unsupervised exercise, the HIIT group will perform the HIIT intervention 3 times a week, at home, unsupervised for 4 weeks. This will be supported by regular contact from a member of the research team to provide support and to encourage adherance.

Our research group has conducted many similar exercise regimes of this intensity to subjects in the anticipated age-range without incident. Participants will be adviced to terminate exercise training immediately if experiencing:

  • Chest pain or tightness
  • Faintness
  • Sudden pallor
  • Loss of co-ordination
  • Confusion
  • Dizziness
  • Palpitations
  • Sudden breathlessness

Should any participant experience these effects during any session, they will be advised to seek urgent medical attention and will be withdrawn from the exercise arm of the study for safety purposes.

干预措施: High intensity interval training (HIIT) (Other)

Resistance exercise training (RET)

Experimental

Older participants (over 60) will be randomized to perform home-based unsupervised exercise, the RET group will perform the RET intervention at home, 3 times a week unsupervised for 4 weeks.This will be supported by regular contact from a member of the research team to provide support and to encourage adherance.

Our research group has conducted many similar exercise regimes of this intensity to subjects in the anticipated age-range without incident. Participants will be adviced to terminate exercise training immediately if experiencing:

  • Chest pain or tightness
  • Faintness
  • Sudden pallor
  • Loss of co-ordination
  • Confusion
  • Dizziness
  • Palpitations
  • Sudden breathlessness

Should any participant experience these effects during any session, they will be advised to seek urgent medical attention and will be withdrawn from the exercise arm of the study for safety purposes.

干预措施: Resistance based training (RET) (Other)

结局指标

主要结局

Mitochondrial activity change with a short-term home-based exercise program in older participants

时间窗: Assessed prior to and after the completion of a 4 week exercise program

The effect of either a resistance exercise-based and high-intensity interval training-based home-based training program on mitochondrial function in those over aged 60 Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes seen throughout the treatment will then be expressed as a percentage in order to express the changes seen from the baseline.

The altered response to training type

时间窗: 4 weeks

The differing responses to either high intensity interval training or resistance based training Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes caused by the training regimen will then be expressed as a percentage in order to express the changes seen from the baseline, and in order to allow comparison between training modality.

Mitochondrial activity across age

时间窗: This will be compared across baseline assessment dates in all ages.

Mitochondrial oxidative phosphorylation capacity changes seen across the age groups investigated Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. This will then be compared across ages and expressed as a ratio of maximal consumption.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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