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

FMD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199949
• Other study ID #: A90355
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• FMD

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery	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	Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
Primary	Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery	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	Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm
Secondary	Hand grip strength	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.	3 minutes