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Sedentary BehaviorCHAINNCT06377254

Multi-organ Responses to CHronic Physical Activity and INactivity

A study testing Decreased Physical Activity and Increased Physical activity in people with Sedentary Behavior and Metabolic Syndrome, run by University of Nottingham at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 65 yearsHealthy volunteers can take part
What is being tested?
Decreased Physical Activity and Increased Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
12 Mar 2024to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paul L Greenhaff (PI), PhD contact

+44 (0) 1158230133

paul.greenhaff@nottingham.ac.uk

Melanie Tooley (participant recruitment), BSc contact

+44 (0) 115 9515151 ext. 19105

melanie.marshall@nottingham.ac.uk

United Kingdom1 site, 1 recruiting
  • David Greenfield Human Physiology Unit

    Nottingham, Notts, NG72UH

    Sara Brown, +44(0)115 8230434, sara.brown@nottingham.ac.uk

    Joanne Mallinson, PhD, +44(0)1158230434, joanne.mallinson@nottingham.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Concurrent Multi-organ Responses to CHronic Physical Activity and INactivity Intervention, to Increase Research Discovery in Human Health and Wellbeing

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.

Read more

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.

Read the detailed description

This is a parallel design study comparing the impact of physical activity and inactivity on the way the body functions, to understand the mechanisms (including the inter-relationship between tissues and organs) by which lifestyle behaviours may effect health and wellbeing in later life. In particular, the mechanisms by which inactivity results in long term poor health is not well understood, and has rarely been studied in an integrated way in people. However, initial research indicates that the physiology of being inactive is not simply the reverse of being active. To enable effective treatments and public health advice to be devised so that more adults reach old age in better health, and maintain a good quality of life for a greater proportion of their older age, it is important that the impact of physical inactivity on the way the body functions is better understood. Therefore, twenty participants who are moderately, but not highly active will be asked to decrease their physical activity for three months to match the average exercise levels of middle-aged people in the United Kingdom (UK). This will require them to increase their daily sitting time to 7 hours a day and reduce their step count to <4500 steps per day. At the end of the 3-months they will undertake 3-months of supervised reconditioning training by attending the Medical School at Queen's Medical Centre, Nottingham, three times a week.

In addition, twenty participants who currently have low physical activity levels will be asked to increase their physical activity to UK recommended levels by attending the Medical School at Queen's Medical Centre, Nottingham, three times a week for six months to undertake a supervised exercise program.

Before and during the 6-month period (at weeks 6, 12, 18 and 24) participants will be asked to make some measurements at home (physical activity levels, dietary intake) and attend the University of Nottingham over 4 days to have multiple assessments made. These include: height; weight; body composition (body fat and lean tissue); blood pressure; fitness, muscle strength and function; sleep quality, quality of life and wellbeing (questionnaires). The rate of muscle protein breakdown and muscle protein synthesis, blood sugar regulation, and biochemistry of the blood, fat tissue and muscles will be assessed, and to enable this muscle and fat tissue biopsies will be collected and blood samples taken. The study also involves having MRI scans to study the structure and function of the brain and heart, and to determine liver and muscle fat content.

Being tested
Decreased Physical Activity, Increased Physical activity
Keywords
Physical activity, middle-age, Physical inactivity, overweight, lifestyle
Medical subject headings
Sedentary Behavior, Metabolic Syndrome, Motor Activity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decreased Physical ActivityBehavioural

    Physical activity levels will be decreased

  • Increased Physical activityBehavioural

    Physical activity levels will be increased

Study groups in NCT06377254
Study groupRoleWhat they receive
InactivityExperimentalParticipants 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.
Receives: Behavioral: Decreased Physical Activity
ActivityExperimentalParticipants in this group will have moderate intensity physical activity levels increased for 6 months, through attending 3x 45 min supervised exercise sessions/week.
Receives: Behavioral: Increased Physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (30)
  1. Change in Isometric leg strength

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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 24 weeks

  5. Change in fasting glucose oxidation rate

    Change in glucose oxidation rate (when fasted), measured every 6 weeks using ventilated hood indirect calorimetry

    Measured: 24 weeks

  6. Change in 'fed' glucose oxidation rate

    Change in glucose oxidation rate (in the insulin-stimulated 'fed' state), measured every 6 weeks using ventilated hood indirect calorimetry during an oral glucose tolerance test

    Measured: 24 weeks

  7. Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score

    Change in 'SF36' Questionnaire aggregated 'physical' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing measured every 6 weeks

    Measured: 24 weeks

  8. Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score

    Change in 'SF36' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better mental wellbeing, measured every 6 weeks

    Measured: 24 weeks

  9. Change in World Health Organisation Quality of Life (WHOQoL) score

    Change in World Health Organisation Quality of Life Score (measured using the WHOQoL-Bref questionnaire every 6 weeks), (min score 0, max 100), with higher score indicating a better state of health.

    Measured: 24 weeks

  10. Change in Pittsburgh Sleep Quality Index (PSQI)

    Change in PSQI score (min score 0, max 21), measured every 6 weeks, with higher score indicating poorer sleep quality

    Measured: 24 weeks

  11. Change in Stroop test; % Accuracy

    Change in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%

    Measured: 24 weeks

  12. Change in Stroop test; reaction time

    Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.

    Measured: 24 weeks

  13. Change in four-choice reaction time test; % Accuracy

    Change in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%

    Measured: 24 weeks

  14. Change in four-choice reaction time test; reaction time

    Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.

    Measured: 24 weeks

  15. Change in card sort test; % Accuracy

    Change in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%

    Measured: 24 weeks

  16. Change in card sort test; reaction time

    Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.

    Measured: 24 weeks

  17. Change in Logical reasoning test; % accuracy

    Change in the accuracy of responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%

    Measured: 24 weeks

  18. Change in Logical reasoning test; reaction time

    Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.

    Measured: 24 weeks

  19. Change in serial subtractions test; number of responses in 2 minutes

    Change in the number of responses, measured every 6 weeks, with higher score indicating better cognitive performance. minimum number is 0, maximum number is variable dependent on starting value (800-999; randomly selected by computer program) and speed of response.

    Measured: 24 weeks

  20. Change in Corsi blocks test; score

    Change in the test score, measured every 6 weeks, with higher score indicating better cognitive performance.Minimum score is 0 and maximum is 15.

    Measured: 24 weeks

  21. Change in Muscle protein synthesis rate

    Muscle synthesis protein rate calculated from deuterium incorporation into muscle tissue

    Measured: 24 weeks

  22. Change in Muscle protein breakdown rate

    Muscle protein breakdown rate calculated every 6 weeks using 3-methylhistidine tracer

    Measured: 24 weeks

  23. Change in whole body fat volumes

    Change in the amount of fat within the body, measured every 6 weeks using magnetic resonance imaging (MRI)

    Measured: 24 weeks

  24. Change in liver fat volumes

    Change in the amount of fat within the liver, measured every 6 weeks using magnetic resonance imaging (MRI)

    Measured: 24 weeks

  25. Change in thigh muscle fat volumes

    Change in the amount of fat within the vastus lateralis thigh muscle, measured every 6 weeks using magnetic resonance imaging (MRI)

    Measured: 24 weeks

  26. Change in whole body muscle volumes

    Change in the amount of muscle within the body, measured every 6 weeks using magnetic resonance imaging (MRI)

    Measured: 24 weeks

  27. Change in muscle phosphocreatine synthesis rate

    Change in the rate of phosphocreatine synthesis, measured every 6 weeks using magnetic resonance spectroscopy

    Measured: 24 weeks

  28. Change in cerebral volume

    Change in the volume of brain tissue, measured every 6 weeks using magnetic resonance imaging (MRI)

    Measured: 24 weeks

  29. Change in cortical thickness

    Change in the thickness of the brain cortex, measured every 6 weeks using magnetic resonance imaging (MRI)

    Measured: 24 weeks

  30. Change in plasma metabolome

    change in untargeted plasma metabolome profile measured every 6 weeks

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start12 Mar 2024
  3. Primary completion17 Dec 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Non-randomised, parallel design lifestyle intervention
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377254
Sponsor's protocol ID
BB/X015173/1
Acronym
CHAIN
Status last verified
Nov 2025
First submitted
11 Apr 2024
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised dataset will be made available to other researchers on request after study aims have been analysed and published. No patient identifiable data will be shared

Questions about this trial

What is this clinical trial studying?

A study testing Decreased Physical Activity and Increased Physical activity in people with Sedentary Behavior and Metabolic Syndrome, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul L Greenhaff (PI), PhD (+44 (0) 1158230133, paul.greenhaff@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiorespiratory fitness (VO2 max) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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