NCT06377254 Multi-organ Responses to CHronic Physical Activity and INactivity
| NCT ID | NCT06377254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Sedentary Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-03-12 with a primary completion date of 2027-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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). * Waist circumference ≥94cm (males) and ≥80cm (females). * Willing to alter physical activity levels as instructed for 6 months * Without neurological or psychiatric diseases, motor or cognitive restrictions * Ability to give informed consent Exclusion Criteria: * 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. * People employed in jobs that would preclude reducing step count and night-shift workers. * Females who are pre/peri-menopausal, (due to effect of oestrogen fluctuations on primary outcomes and the longitudinal study design), but individuals stable on hormone replacement therapy are eligible. * Contraindications for MRI. * Allergy or sensitivity to local anaesthesia, or dressing adhesive
Contact & Investigator
Paul L Greenhaff, PhD
PRINCIPAL INVESTIGATOR
University of Nottingham
Frequently Asked Questions
Who can join the NCT06377254 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 65 Years, studying Sedentary Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06377254 currently recruiting?
Yes, NCT06377254 is actively recruiting participants. Contact the research team at paul.greenhaff@nottingham.ac.uk for enrollment information.
Where is the NCT06377254 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT06377254 clinical trial?
NCT06377254 is sponsored by University of Nottingham. The principal investigator is Paul L Greenhaff, PhD at University of Nottingham. The trial plans to enroll 40 participants.