Effects of changing physical activity levels on health in middle-aged adults

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

This study tests how changing physical activity levels—either cutting back or increasing exercise—affects health in middle-aged adults, especially looking at issues like metabolic syndrome and cognitive decline.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 50 Years to 65 Years
• Sex: All
• Sponsor: University of Nottingham (other)
• Locations: 1 site (Nottingham, Notts)
• Trial ID: NCT06377254 on ClinicalTrials.gov

What this trial studies

This intervention compares the effects of increased and decreased physical activity on health outcomes in middle-aged adults. Participants will be divided into two groups: one will reduce their activity to match sedentary levels, while the other will increase their activity to recommended levels. The study aims to understand the physiological mechanisms behind how inactivity affects health and well-being, particularly in relation to metabolic syndrome and cognitive decline. Over six months, participants will adjust their activity levels, followed by a three-month supervised reconditioning phase to restore fitness.

Who should consider this trial

Good fit: Ideal candidates are middle-aged adults aged 55-65 who are either moderately active or sedentary and are overweight.

Not a fit: Patients with chronic diseases or those on medications that could interfere with the study's measures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective lifestyle interventions that improve health and quality of life for older adults.

How similar studies have performed: Previous studies have indicated that lifestyle interventions can significantly impact health outcomes, suggesting potential success for this approach.

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

Where this trial is running

Nottingham, Notts

• David Greenfield Human Physiology Unit — Nottingham, Notts, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Paul L Greenhaff, PhD — University of Nottingham
• Study coordinator: Paul L Greenhaff (PI), PhD

Conditions: Sedentary Behavior, Metabolic Syndrome, Age-related Cognitive Decline, Age-Related Sarcopenia, Physical activity, middle-age, Physical inactivity, overweight