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

• Sponsor: University of Nottingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT04199949
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
FMD	Behavioral: Inactivity	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 5 consecutive days of normal daily levels of physical activity and matched food intake
Experimental: 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	Behavioral: Inactivity; On days 1 and 6 of each main trial, the participants will be asked to attend the laboratory after an overnight fast of at least 8 to 12h to undergo brachial and popliteal arteries FMD measurements (30 min apart) using duplex-Doppler ultrasound, followed by assessment of the hand grip strength of their non-dominant hand using a hand dynamometer.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Nottingham	Nottingham	Nottinghamshire	United Kingdom	NG7 2RD

Sponsors and Collaborators

• University of Nottingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moira Taylor, Dr Moira A Taylor, University of Nottingham
• ClinicalTrials.gov Identifier: NCT04199949
• Other Study ID Numbers: A90355
• First Posted: Dec 16, 2019
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 23, 2022