Intermittent Hypoxia and Balance Control

NCT05463042 | Completed

• 1 other identifier: STUDY00003081
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of acute mild intermittent hypoxia on ankle plantarflexor muscle output during balance regulation and walking in younger and older adults. Fifteen younger adults and 15 older adults will be recruited to participate in the cross-over design study that requires 2 visits (at least 1-week apart). Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit. Muscle activation patterns and kinetic and kinematics during standing and walking will be recorded before and after the intermittent hypoxia/sham. It is hypothesized that compared to the sham condition, both younger and older participants will show greater increases in ankle plantarflexor muscle activation during gait and balance assessments following intermittent hypoxia.

Conditions

Intermittent Hypoxia; Normoxia

Outcome Measures

Primary Outcomes (2)

• Soleus muscle activation pattern

  changes in peak soleus muscle EMG magnitude following perturbation onset during standing from pre to post intermittent hypoxia will be calculated

  pre (2o minutes before) and post (20 minutes after) intermittent hypoxia or sham session

• Ankle plantarflexion torque

  Changes in peak ankle plantarflexion torque production during walking from pre to post intermittent hypoxia will be calculated.

  pre (20 minutes before) and post (20 minutes after) intermittent hypoxia or sham session

Study Arms (2)

Intermittent Hypoxia

EXPERIMENTAL

Participants will receive intermittent hypoxia and perform balance and gait assessments before and after the intermittent hypoxia session.

Behavioral: Intermittent Hypoxia

Normoxia (sham)

SHAM COMPARATOR

Participants will receive normoxia and perform balance and gait assessments before and after the normoxia session.

Behavioral: Normoxia (sham)

Interventions

Intermittent Hypoxia BEHAVIORAL

During the intermittent hypoxia session, participants will be sitting during the entire breathing protocol. Hypoxic air will be inhaled through a mask connected to a two-way non-rebreathing valve, which will itself be connected to a 5-liter non-diffusing gas bag (Hans Rudolph, Inc, USA). The rebreathing bag will be connected to a certified medical grade gas tank containing 11% oxygen and a balance of nitrogen. The intermittent hypoxia protocol will consist of eight 4-min cycles of breathing hypoxic air interspersed with normoxic cycles breathing room air. After four min of hypoxia, participants will be switched back to breathing room air until resaturation, which takes approximately one minute. Once arterial oxygen saturation reaches baseline levels, participants will be switched back to breathing hypoxic air, beginning the next hypoxic cycle.

Intermittent Hypoxia

Normoxia (sham) BEHAVIORAL

During the sham condition, compressed air (21% oxygen) from a gas tank will be delivered throughout the protocol instead of 11% oxygen. Participants will not receive information about which condition (Intermittent hypoxia or sham) they are experiencing during the trials.

Normoxia (sham)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Able to stand and walk for more than 5 minutes without assistance.

You may not qualify if:

• Have high blood pressure (above 130/90 mmHg)
• Are smokers
• Are pregnant
• Have body mass index more than 35 kg/m2
• Have a history of falls in the past 6 months
• Have a history of neuromuscular deficits that may affect gait
• Have a history of cardiovascular disease
• Have a history of diabetes or lung disease
• Are taking medication affecting the cardiovascular system

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Mateika JH, El-Chami M, Shaheen D, and Ivers B. Intermittent hypoxia: a low-risk research tool with therapeutic value in humans. J Appl Physiol (1985). 2015. 118(5): 520-32. Meerson F, Pozharov V, and Minyailenko T. Superresistance against hypoxia after preliminary adaptation to repeated stress. J Appl Physiol (1985). 1994. 76(5): 1856-61. Neubauer JA. Invited review: Physiological and pathophysiological responses to intermittent hypoxia. J Appl Physiol (1985). 2001. 90(4): 1593-9. Casey DP, Shepherd JR, and Joyner MJ. Sex and vasodilator responses to hypoxia at rest and during exercise. J Appl Physiol (1985). 2014. 116(7): 927-36. Casey DP, Walker BG, Curry TB, and Joyner MJ. Ageing reduces the compensatory vasodilatation during hypoxic exercise: the role of nitric oxide. J Physiol. 2011. 589(Pt 6): 1477-88. Jarrard CP, Nagel MJ, Stray-Gundersen S, Tanaka H, and Lalande S. Hypoxic preconditioning attenuates ischemia-reperfusion injury in young healthy adults. J Appl Physiol (1985). 2021. 130(3): 846-852. Nagel MJ, Jarrard CP, and Lalande S. Effect of a Single Session of Intermittent Hypoxia on Erythropoietin and Oxygen-Carrying Capacity. Int J Environ Res Public Health. 2020. 17(19). Wojan F, Stray-Gundersen S, Nagel MJ, and Lalande S. Short exposure to intermittent hypoxia increases erythropoietin levels in healthy individuals. J Appl Physiol (1985). 2021. 130(6): 1955-1960. Wesseling KH, Jansen JR, Settels JJ, and Schreuder JJ. Computation of aortic flow from pressure in humans using a nonlinear, three-element model. J Appl Physiol (1985). 1993. 74(5): 2566-73.

  BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed about which condition (intermittent hypoxia or normoxia) they are experiencing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a cross-over design study that requires 2 visits (a least 1-week apart). Fifteen younger adults and 15 older adults will be recruited. Participants will be pseudo-randomly assigned to receive either intermittent hypoxia or sham during the first visit, and then switch over to receive sham or intermittent hypoxia during the 2nd visit.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 18, 2022
• Study Start: September 1, 2022
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available following the completion of data analyses for 10 years.

Locations

US (1)