Multi-organ Responses to CHronic Physical Activity and INactivity

NCT06377254 | Recruiting DMC

• 1 other identifier: BB/X015173/1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior; Metabolic Syndrome; Age-related Cognitive Decline; Age-Related Sarcopenia

Keywords

Physical activity; middle-age; Physical inactivity; overweight; lifestyle

Outcome Measures

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

  12 weeks

Secondary Outcomes (30)

• Change in Isometric leg strength

  24 weeks

• Change in time to leg fatigue

  24 weeks

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

  24 weeks

• Change in iAUC for serum insulin concentration

  24 weeks

• Change in fasting glucose oxidation rate

  24 weeks

Other Outcomes (35)

• Fasting blood lipid concentration

  pre-intervention

• Fasting blood lipid concentration

  6 weeks

• Fasting blood lipid concentration

  12 weeks

Study Arms (2)

Inactivity

EXPERIMENTAL

Participants in this group will reduce their physical activity (increase sitting time to 7hrs/day and decrease step count to \<4500/day) for 3 months, then increase their activity for 3 months, through attending 3x 45 min supervised exercise sessions/week.

Behavioral: Decreased Physical Activity

Activity

EXPERIMENTAL

Participants in this group will have moderate intensity physical activity levels increased for 6 months, through attending 3x 45 min supervised exercise sessions/week.

Behavioral: Increased Physical activity

Interventions

Increased Physical activity BEHAVIORAL

Physical activity levels will be increased

Activity

Decreased Physical Activity BEHAVIORAL

Physical activity levels will be decreased

Inactivity

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

David Greenfield Human Physiology Unit

Nottingham, Notts, NG72UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Metabolic Syndrome; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul L Greenhaff, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul L Greenhaff (PI), PhD

CONTACT

+44 (0) 1158230133; paul.greenhaff@nottingham.ac.uk

Melanie Tooley (participant recruitment), BSc

CONTACT

+44 (0) 115 9515151; melanie.marshall@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those undertaking analysis of biological samples and MRI data will be masked as to the group the participant is allocated to.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-randomised, parallel design lifestyle intervention

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 22, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available approximately 2 years after study completion and will be available for 20 years
• Access Criteria: Although parts of the data set generated from this project will be available on open access platforms to support publications, access to the full data repository and tissue archive will be through requests made to the Management Board. Access will be subject to ethical constraints, the preservation of intellectual property (IP), and written acknowledgement that it is a research collaboration, with data ownership residing with the original research teams. Data will be shared subject to a data transfer agreement and confirmation that deletion of the shared data set will occur once analysis has been completed.

Locations

GB (1)