NCT06853275

Brief Summary

The overall objective for this clinical trial is to provide evidence for internal and external cueing for physical therapists and other rehabilitation clinicians to optimize resistance training within rehabilitation for older adults. The main questions it aims to answer are:

  • What is the impact of external focus (providing velocity of movement for each repetition) compared to internal focus (i.e., no cues, control group) on physical percent velocity loss and neuromuscular activation in older adults with sarcopenia?
  • Does internal and external focus influence motivation and perceptual workload following resistance training in older adults with sarcopenia? Researchers will compare external focus to internal focus to see if external focus impacts percent velocity loss, motivation, and perceived workload. Participants will:
  • Visit the lab once per week for 3 weeks
  • Perform exercise testing using a leg press
  • Answer questionnaires regarding perceived workload and motivation before and after exercise

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

February 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2026

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

February 25, 2025

Last Update Submit

March 16, 2026

Conditions

Keywords

GeriatricsNeuromuscularRehabilitationSarcopeniaVelocity-based training

Outcome Measures

Primary Outcomes (4)

  • Percent Velocity Loss

    The linear position transducer is a spring-powered retractable apparatus that attaches to the leg press on one end and to the machine near the participant's hip joint. Velocity data from a linear position transducer will be collected following each repetition. Percent velocity loss (%VL) measures the reduction in the movement speed from the initial repetition to the final repetition. The %VL will quantify the level of fatigue and performance decline that occurs throughout the repetitions of leg press. This would suggest that a higher %VL would indicate a greater degree of fatigue, while a lower %VL loss would indicate a better ability to maintain movement velocity across the repetitions.

    Week 1 and Week 2 Timepoints

  • Muscle Activation

    To examine muscle activation, surface electromyographic (sEMG) signals will be collected in millivolts (mV) during each repetition using wireless sEMG sensors from the right vastus lateralis. A higher number of millivolts is associated with greater muscular activation. All sEMG signals will use a commercially available signal acquisition system. To optimize signal quality, the skin will be prepared, and the surface electrodes will be secured to the skin with skin-sensor adhesive in a standardized position directly above the muscle in line with the muscle fiber pennation in a bipolar fashion. An electrogoniometer will be placed across the right knee's joint space. The electrogoniometer will be calibrated to 90° flexion and 180° full extension of the knee joint.

    Baseline, Week 1, and Week 2 Timepoints

  • Motivation

    The Dundee Stress State Questionnaire (DDSQ) has been used to determine task stress and performance impact of stress on task completion. Our proposal focuses on the motivation construct (15 item questionnaire, \~5 minutes to complete) of the DDSQ which has been shown to be reliable and scored on a 4-point Likert scale (Extremely = 4 Very much = 3 Somewhat = 2 A little bit = 1 Not at all = 0). The maximum score possible is 60 points and minimum score possible is 0 points. Higher scores indicate higher motivation. Note that certain items are reverse coded when scoring. Motivation will be assessed before sessions to determine baseline motivation to complete the resistance training protocol and 10 minutes after the resistance training protocol to determine if the visual movement velocity biofeedback improves motivation throughout the resistance training protocol.

    Week 1 and Week 2 Timepoints

  • Perceived Workload

    Perceived workload will be assessed using the NASA task index (NASA-TLX). This questionnaire assesses six separate indices that examine the mental demand, physical demand, temporal demand, performance, effort, and frustration level following the completion of the resistance training protocol. Adjusted scores range from 0-500 with higher scores indicate greater demand, failure, higher effort, or higher frustration. The NASA-TLX will provide valuable information about how visual movement velocity biofeedback may change the perceived workload compared to the non-biofeedback condition.

    Week 1 and Week 2 Timepoints

Study Arms (2)

External Focus

EXPERIMENTAL
Behavioral: Experimental: External Focus

Internal Focus

OTHER
Behavioral: Other: Internal Focus

Interventions

Arm Description: Participants will perform a short, standardized warm-up (1 set of 10 repetitions of 20% of the participant's estimated 1RM). Following the warm-up, participants will perform 30 repetitions using 50% of their estimated 1-repetition maximum on a leg press machine. Participants will NOT receive visual feedback for each repetition. This is the control condition.

Internal Focus

Participants will perform a short, standardized warm-up (1 set of 10 repetitions of 20% of the participant's estimated 1-repetition maximum). Following the warm-up, participants will perform 30 repetitions using 50% of their estimated 1-repetition maximum on a leg press machine. Participants will receive visual feedback from a linear position transducer for each repetition, indicating the speed of the last repetition/movement.

External Focus

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling older adults 60-95 years of age
  • Physically independent
  • Free of severe mental impairment
  • Score 4 or greater on the SARC-F sarcopenia questionnaire

You may not qualify if:

  • Participated in a structured resistance training program in the last 12 months
  • Had a lower extremity injury or surgical intervention within the past 6 months
  • Have neuromuscular (i.e., Parkinson's Disease, Multiple Sclerosis), circulatory, or edema pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Rashelle Hoffman, PT, DPT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

February 28, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The study data will be housed in the Creighton Digital Repository. Sharing beyond this registry will be handled on a case-by-case basis.

Locations