NCT04614857

Brief Summary

The purpose of this study was to determine the effect of lower extremity muscle activity on the increase of cardiopulmonary metabolic cost during inclined treadmill gait in the elderly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
Last Updated

April 15, 2021

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 28, 2020

Last Update Submit

April 13, 2021

Conditions

Keywords

Muscle activityCardiopulmonary metabolic cost

Outcome Measures

Primary Outcomes (1)

  • Change on metabolic energy expenditure

    All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)

    1 hour

Secondary Outcomes (1)

  • Change on muscle activity

    1 hour

Study Arms (1)

Inclined treadmill gait

EXPERIMENTAL

All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)

Other: Inclined treadmill gait

Interventions

All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)

Inclined treadmill gait

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Between 65 and 84 years elderly without neurological effects
  • Ability to independent gait at least 16% inclined treadmill
  • High levels of physical performance (SPPB \> 7)

You may not qualify if:

  • Severe visual impairment or dizziness that increases the risk of falls
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery, history of congestive heart failure, documentedserious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy,severe aortic stenosis, angina or dyspnea at rest or during activities ofdaily living)
  • Difficult to understand experimental tasks because of extremely severe cognitive impairment
  • Recent acute injuries such as fractures within 6 months, or experience in orthopedic surgery such as artificial joint replacement
  • Acute injuries such as fractures within 6 months or orthopedic surgery such as artificial joint replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Kim J, Lee HJ, Lee SH, Lee J, Chang WH, Ryu GH, Kim YH. Correlation between cardiopulmonary metabolic energy cost and lower-limb muscle activity during inclined treadmill gait in older adults. BMC Geriatr. 2021 Aug 23;21(1):469. doi: 10.1186/s12877-021-02401-9.

Study Officials

  • Yun-Hee Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 4, 2020

Study Start

November 5, 2020

Primary Completion

January 8, 2021

Study Completion

February 26, 2021

Last Updated

April 15, 2021

Record last verified: 2020-10

Locations