Multi-organ Responses to CHronic Physical Activity and INactivity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-65
SponsorUniversity of Nottingham

About this trial

Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual.

Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day.

To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.

The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for three months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.

Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;

* fitness, muscle strength and function tests, * completion of questionnaires and computer-based brain puzzles * having muscle and fat tissue biopsies and blood samples taken. * The study also involves having MRI scans.

This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Group 1 ('non-sedentary') self-reporting <6 sedentary hrs/day, not actively involved in exercise training or a regular physical activity regimen (>8,000 steps/day).

Group 2 ('sedentary') self-reporting ≥8 waking hrs/day in sedentary activities and/or ≤5,000 steps/day.

Aged 50-65y.

Overweight (BMI 25-35 kg/m2).

Disqualifiers

Regular medication use that could interfere with measures

A history, or evidence, of chronic cardiovascular, metabolic, musculoskeletal, renal or respiratory diseases.

Experiencing 'long-COVID', inflammatory bowel disease or malignancy.

Uncontrolled hypertension. Stage 1 hypertension (BP ≤160/100mmHg) with no other signs of cardiovascular disease, and blood pressure (BP) managed by routine medication will not be an exclusion.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Decreased Physical Activity

    Behavioral

    Physical activity levels will be decreased

  • Increased Physical activity

    Behavioral

    Physical activity levels will be increased

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InactivityExperimental treatment 1 intervention
Group B: ActivityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Cardiorespiratory fitness (VO2 max)

change in maximal oxygen uptake (continuous incremental bicycle ergometer exercise test with on-line gas analysis) measured every 6 weeks

Time frame
12 weeks

Secondary outcomes

1

Change in Isometric leg strength

Change in Isometric leg strength measured every 6 weeks using CYBEX dynamometer

Time frame
24 weeks
2

Change in time to leg fatigue

Change in time taken to induce muscle fatigue measured every 6 weeks using isokinetic knee extensions on a CYBEX dynamometer

Time frame
24 weeks
3

Change in incremental area under the curve (iAUC) for blood glucose concentration

Change in 180 minute blood glucose concentration incremental area under the curve measured every 6 weeks during an oral glucose tolerance test.

Time frame
24 weeks
4

Change in iAUC for serum insulin concentration

Change in 180-minute serum insulin concentration incremental area under the curve measured every 6 weeks during an oral glucose tolerance test

Time frame
24 weeks

Other outcomes

1

Fasting blood lipid concentration

concentration of lipid within the blood

Time frame
pre-intervention
2

Fasting blood lipid concentration

concentration of lipid within the blood

Time frame
6 weeks
3

Fasting blood lipid concentration

concentration of lipid within the blood

Time frame
12 weeks
4

Fasting blood lipid concentration

concentration of lipid within the blood

Time frame
18 weeks

Sponsors and contacts

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University of Nottingham

Lead sponsor

Biotechnology and Biological Sciences Research Council

Collaborator