Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans

Not Applicable

Completed

• Conditions: FMD
• Interventions: Behavioral: Inactivity

• Registration Number: NCT04199949
• Lead Sponsor: University of Nottingham

Brief Summary

Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. The investigators aim is to assess the vascular (endothelial) function before and after a 5-day period of reduced activity of upper and lower limbs via an arm sling and daily step counts reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years), healthy, males and females, recreationally active with a body mass index between 18 and 27 kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions: (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control trial combined with their non-dominant arm placed in a sling and a reduction in food (energy) intake (\~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial and popliteal arteries, and hand grip strength will be measured.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Non-smoking
• Males
• Age (18-35 years old)
• Body mass index (BMI) of 18-27 kg/m2
• Recreationally active
• Ability to give informed consent

Exclusion Criteria

• Smoking
• Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
• Clinically significant abnormalities on screening including ECG abnormalities
• Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
• Well-trained individuals
• On an energy-restricted diet or seeking to lose weight
• High alcohol consumption (<3-4 units/day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inactivity	Inactivity	5 consecutive days of reduced step count by 80% compared to the Control trial, whilst placing the non-dominant arm in a sling, and reduced food intake (\~ 20%) to match the reduction in energy expenditure induced by inactivity

Primary Outcome Measures

Name	Time	Method
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery	Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm	The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes
Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery	Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm	The FMD of the popliteal artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes

Secondary Outcome Measures

Name	Time	Method
Hand grip strength	3 minutes	The hand grip strength will be measured using a hand dynamometer. Three maximum hand grips separated by one minute rest at the end of each visit.

Trial Locations

Locations (1)

The University of Nottingham; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom