NCT05697497

Brief Summary

This study is a randomized trial of 100 older adults with mobility disability, who performed a similar brief daily, resistance training program. The investigators set out to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" To answer that question, participants were assigned to an intervention or delayed-treatment control group. Intervention participants were assigned to complete two 30-second lower body exercises and two 30-second upper body exercises. Fitness tests were completed remotely three times during the 12-weeks (i.e., at baseline, week 6, week 12).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

February 8, 2022

Last Update Submit

July 8, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • 30-Second Chair Stand

    Leg strength and endurance test - number of chair stand repetitions in 30 seconds

    Baseline

  • 30-Second Chair Stand

    Leg strength and endurance test - number of chair stand repetitions in 30 seconds

    6 weeks

  • 30-Second Chair Stand

    Leg strength and endurance test - number of chair stand repetitions in 30 seconds

    12 weeks

  • Five Time Sit to Stand Test (5TSTS)

    The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

    Baseline

  • Five Time Sit to Stand Test (5TSTS)

    The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

    6 weeks

  • Five Time Sit to Stand Test (5TSTS)

    The Five Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements. The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.

    12 weeks

  • Single Leg Stance Test (SLS)

    Assessment of static postural and balance control.

    12 weeks

  • Functional limitations

    Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey

    12 weeks

  • Falls

    Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.

    12 weeks

Secondary Outcomes (6)

  • Walking gait cadence

    10 day period pre and post intervention

  • Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey

    12 weeks

  • Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey

    12 weeks

  • Self-Efficay for Physical Activity (SEPA)

    12 weeks

  • Percent of sessions attended

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention Condition

EXPERIMENTAL

The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises.

Behavioral: Daily exercise intervention

Delayed-Treatment Control Group

NO INTERVENTION

The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises. Participants in the this arm will not start the exercise intervention until the day after the week 12 assessment.

Interventions

Participants will complete four exercises each day, The first two weeks they will be instructed to complete as many repetitions as possible, each day, for 15 seconds and progressing to 30 seconds per exercise after the first two weeks. Participants are asked to increase their goal repetitions by 1 or 2 from their previous best each week. For all exercises with modifications, we will encourage participants to move to the next most difficult modification once they can do 15 repetitions of that exercise.

Intervention Condition

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 and older
  • Difficulty with walking
  • Providers must provide consent for their patient
  • Access to the internet
  • Must have a camera on computer, tablet, or smartphone
  • Fluent in Egnlish

You may not qualify if:

  • Chest pain or a heart condition on the PAR-Q
  • Planning to have surgery in the next 3 months
  • Cognitive impairment
  • Unable to exercise
  • Being currently physically active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A delayed treatment control group will be used to compare the effects of the intervention to a control group. Both groups will complete their study visits at baseline, week 6, and week 12, with the intervention group starting their exercises immediately after the baseline visit and the delayed treatment control group starting their exercise intervention after their week 12 visit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair for Research Affairs, Department of Medicine

Study Record Dates

First Submitted

February 8, 2022

First Posted

January 26, 2023

Study Start

May 1, 2021

Primary Completion

January 6, 2022

Study Completion

January 6, 2022

Last Updated

July 11, 2025

Record last verified: 2025-07

Locations