search
Back to results

NM Balance Regulation With ULLS and Loss of Sleep

Primary Purpose

Muscle Weakness, Quadriceps Muscle Atrophy, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Restriction
Sleep Adequate
Sponsored by
Lance Bollinger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Weakness focused on measuring sleep restriction, spaceflight, unweighting, posture

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep Restriction (SR)

Sleep Adequate (SA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2023
Last Updated
August 18, 2023
Sponsor
Lance Bollinger
Collaborators
National Aeronautics and Space Administration (NASA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05956964
Brief Title
NM Balance Regulation With ULLS and Loss of Sleep
Official Title
Effects of Unloading and Sleep Restriction on Balance Regulation and Quadriceps Structure and Contractile Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lance Bollinger
Collaborators
National Aeronautics and Space Administration (NASA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Quadriceps Muscle Atrophy, Sleep Disturbance
Keywords
sleep restriction, spaceflight, unweighting, posture

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to different arms via a matched-pairs design using the following criteria: age, sex, and race. Within each arm, the loaded limb will serve as an internal control to assess effects of unloading.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Restriction (SR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep Adequate (SA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Restriction
Intervention Description
5 hours of sleep for 3 days
Intervention Type
Behavioral
Intervention Name(s)
Sleep Adequate
Intervention Description
9 hours of sleep for 3 days
Primary Outcome Measure Information:
Title
Change in Interpolated Twitch
Description
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).
Time Frame
Baseline and study completion, approximately 14 days
Title
Change in Single Leg Stand (SLS)
Description
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
Time Frame
Baseline and study completion, approximately 14 days
Title
Muscle volume
Description
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.
Time Frame
Post-intervention, approximately 14 days after start of study
Title
Change in Single Leg Land and Hold
Description
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.
Time Frame
Baseline and study completion, approximately 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lance Bollinger, PhD
Phone
8593518709
Email
lance.bollinger@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Bollinger, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Bollinger, PhD
Phone
859-257-7904
Email
lance.bollinger@uky.edu

12. IPD Sharing Statement

Learn more about this trial

NM Balance Regulation With ULLS and Loss of Sleep

We'll reach out to this number within 24 hrs