NM Balance Regulation With ULLS and Loss of Sleep

Effects of Unloading and Sleep Restriction on Balance Regulation and Quadriceps Structure and Contractile Function

The goal of this trial is to learn about how restricted sleep and not bearing weight on the leg affects muscle strength and posture control. Participants will walk exclusively on one leg, sleep at differing intervals, and complete posture tests, muscle strength tests, and muscle imaging. Researchers will compare adequate sleep and restricted sleep to see if muscle strength and posture are affected.

Study Overview

• Status: Recruiting
• Conditions: Muscle Weakness; Sleep Disturbance; Quadriceps Muscle Atrophy
• Intervention / Treatment: Behavioral: Sleep Restriction; Behavioral: Sleep Adequate

Detailed Description

During space flight, astronauts experience multiple physiological stimuli (such as microgravity and altered sleep cycles) which independently impair balance and strength. The goal of this project is to determine how these stimuli interact to affect static single-leg balance, balance during dynamic tasks, and muscle recruitment, strength, and remodeling.

Subjects (healthy adults age 18-50) will complete 13 days of unilateral lower limb suspension (ULLS, the gold standard analog for measuring space flight in ambulatory subjects). For the final three days of the study, subjects will be randomly assigned (via a matched pairs approach) to either normal sleep (7-9 hours per night) or restricted sleep (5 hours per night). Before and after the study, subjects will complete balance assessments and measures of muscle strength and recruitment. At the end of the study, subjects will also undergo diffusion tensor imaging for the thighs.

Balance testing will be conducted by examining sway in center of gravity during single leg stance and when stepping down from a box. Muscle strength and recruitment will be assessed via submaximal and maximal voluntary isometric contractions. Additionally, an interpolated twitch experiment will be performed to assess muscle recruitment and twitch properties. Diffusion Tensor imaging will be used to quantify muscle size and structure.

As prophylactic treatment against deep vein thrombosis (the major risk of ULLS), subjects will take an aspirin (81mg daily), wear compression stockings, complete passive range of motion exercises, and use intermittent pneumatic compression devices during sedentary times.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lance Bollinger, PhD; Phone Number: 8593518709; Email: lance.bollinger@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky
      • Contact: Lance Bollinger, PhD; Phone Number: 859-257-7904; Email: lance.bollinger@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 and 50 years
• Regularly engaging in aerobic exercise (> 150min/wk) and resistance exercise (>1 time per week) for the past 12 months
• Regularly sleep at least 7 hours per night

Exclusion Criteria:

• Age < 18 or > 50 years
• Height between <150 (F) or <170 (M) and > 190 cm (both sexes)
• Waist circumference < 55cm or > 90cm (F) and < 75cm or > 100cm (M)
• Body mass index < 18.5 or > 27.5
• Do not regularly sleep between 7 and 9 hours each night
• Have a known sleep disorder
• Not regularly engaging in exercise for previous 12 months
• Blood clotting disorder
• Heart arrhythmia
• Implanted device which could negatively be affected by electrical impulse or strong magnetic field such as pacemaker, internal defibrillator, or cochlear implant
• Diagnosed cardiovascular, pulmonary, renal, or metabolic disease
• Pregnancy (within previous 6 months)
• Oral contraceptive use (within previous three months)
• High resting blood pressure (>140 systolic and/or > 90 diastolic)
• Currently or previously undergone gender-affirming therapy (hormone therapy or sexual reassignment surgery)
• Low back or leg injury in previous 6 months
• Currently taking medication to assist with sleep
• Muscle, bone, or joint injury that limits physical activity within previous 6 months
• Neurological disorder which affects balance (such as multiple sclerosis or Parkinson's disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Restriction (SR); The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SR group will sleep only 5 hours for three consecutive nights.	Behavioral: Sleep Restriction; 5 hours of sleep for 3 days
Active Comparator: Sleep Adequate (SA); The research team will provide participants with a pair of shoes to wear throughout the study. The right shoe will be modified to include a 5cm (approximately 2") rocker-style platform which will keep the left leg suspended during walking. Participants will also be provided with a pair of short crutches to assist with walking. Participants in the SA group will sleep for 9 hours for three consecutive nights.	Behavioral: Sleep Adequate; 9 hours of sleep for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interpolated Twitch	Subjects will sit upright in an isokinetic dynamometer with the knee at 60° flexion. Gel electrode pads will be placed over the femoral nerve and just proximal to the patellar tendon. Square wave, constant current, doublet pulses from an electrical stimulator will be used to evoke twitches prior to, during, and following a maximal voluntary isometric contraction (MVIC).	Baseline and study completion, approximately 14 days
Change in Single Leg Stand (SLS)	Balance will be assessed using a dual force plate system. Participants will be asked to stand on one leg and maintain their balance for 15 seconds	Baseline and study completion, approximately 14 days
Muscle volume	Diffusion Tensor Imaging (DTI) will be used to quantify muscle volume. Subjects will lay supine, and slightly flex the knee (~10°) to elongate and straighten the quadriceps. A spine array coil will be placed on the MR-scanner table and a flexible body coil wrapped around the upper thigh and centered over mid-thigh of the dominant leg. Multiple images will be taken. DSI Studio program will be used to analyze raw images.	Post-intervention, approximately 14 days after start of study
Change in Single Leg Land and Hold	Balance will be assessed using a dual force plate system. Participants will step off a wooden platform and land with one leg only in the middle of the respective force plate. As soon as the participant lands, they will be asked to maintain their position for 10 seconds.	Baseline and study completion, approximately 14 days

Collaborators and Investigators

• Sponsor: Lance Bollinger
• Collaborators: National Aeronautics and Space Administration (NASA)
• Investigators: Principal Investigator: Lance Bollinger, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: spaceflight; posture; sleep restriction; unweighting
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscle Weakness; Dyssomnias; Parasomnias; Muscular Atrophy
• Other Study ID Numbers: 84290

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No