Walking, DifficultyFASTNCT05697497
Functional Activity Strength Training
A study testing Daily exercise intervention in people with Walking, Difficulty, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Walking, Difficulty
- What is being tested?
- Daily exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 6 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Brief Digital Exercise Program to Improve Physical Function Among Older Adults
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).
Read the detailed description
This is a 12-week delayed-control randomized trial to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" Participants who screen eligible will be assigned to one of four conditions, an immediate workout group, an immediate workout group with activity monitor, a delayed workout group or a delayed workout group with activity monitor. Participants will complete a daily 4-minute exercise routine at home and to record their results using an electronic survey. Other outcome measurements will be conducted remotely at baseline, 6, and 12 weeks.
The investigators hypothesize that participants in the AMRAP condition will report significant reductions in functional physical limitations, increased gait speed, and increased physical performance (i.e., increased exercise repetitions) from baseline to 6 weeks compared to those randomized to the delayed-treatment control.
- Conditions
- Walking, Difficulty
- Being tested
- Daily exercise intervention
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily exercise interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | The exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Second Chair Stand
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Measured: Baseline
30-Second Chair Stand
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Measured: 6 weeks
30-Second Chair Stand
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Single Leg Stance Test (SLS)
Assessment of static postural and balance control.
Measured: 12 weeks
Functional limitations
Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey
Measured: 12 weeks
Falls
Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.
Measured: 12 weeks
Secondary outcomes (6)
Walking gait cadence
Gait cadence will be measured in 50% of the participants using an activPAL device.
Measured: 10 day period pre and post intervention
Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Survey using questions from the NIH-supported Patient Reported Outcomes Measurement Information System (PROMIS). The minimal value for pain interference is not at all, while the minimum value for pain intensity is no pain. The maximum value for pain interference is very much, while the maximum value for pain intensity is worst pain imaginable. A higher score generally means a worse outcome.
Measured: 12 weeks
Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Survey using questions from the NIH-supported Patient Reported Outcomes Measurement Information System (PROMIS). The minimum value for fatigue is not at all, while the maximum value is very much. A higher score generally means a worse outcome.
Measured: 12 weeks
Self-Efficay for Physical Activity (SEPA)
5-item measure that assesses an individual's confidence for engaging in exercise in the presence of barriers.
Measured: 12 weeks
Percent of sessions attended
Patients will be considered adherent to the intervention when they enter their daily exercise performance data via daily survey. The percent of sessions attended will be calculated by dividing the number of sessions attended by the total number of sessions offered and multiplying the result by 100.
Measured: 12 weeks
Heart rate
resting and maximal heart rates will be collected during the maximal exercise performance tests
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 May 2021
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Walking, DifficultyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Penn State Health Milton S Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697497
- Sponsor's protocol ID
- STUDY00016054
- Acronym
- FAST
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dandekar S, Kurth J, Shang Y, Stine JG, Ladwig MA, Conroy DE, Schmitz KH, Rovniak LS, Silvis M, Danilovich M, Ballentine N, Pierwola-Gawin N, Zhou S, Sciamanna C. Brief daily functional strength training to improve functional performance in older adults with mobility disability: A randomized trial. PLoS One. 2026 Mar 12;21(3):e0336748. doi: 10.1371/journal.pone.0336748. eCollection 2026.
PubMed 41818188
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Digital Exercise Program to Improve Physical Function Among Older Adults
- ClinicalTrials.gov ID
- NCT05697497
- Acronym / sponsor ID
- FAST / STUDY00016054
- Conditions
- Walking, Difficulty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a 12-week delayed-control randomized trial to answer the following question "Will a digital, brief daily exercise program be feasible, acceptable, and effective among older adults with walking limitations?" Participants who screen eligible will be assigned to one of four conditions, an immediate workout group, an immediate workout group with activity monitor, a delayed workout group or a delayed workout group with activity monitor. Participants will complete a daily 4-minute exercise routine at home and to record their results using an electronic survey. Other outcome measurements will be conducted remotely at baseline, 6, and 12 weeks.
The investigators hypothesize that participants in the AMRAP condition will report significant reductions in functional physical limitations, increased gait speed, and increased physical performance (i.e., increased exercise repetitions) from baseline to 6 weeks compared to those randomized to the delayed-treatment control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Daily exercise interventionThe exercise intervention consists of a 4 minute daily routine that includes 2 upper body and 2 lower body exercises. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily exercise interventionParticipants 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. | Behavioural | Intervention Condition |
Primary outcome
30-Second Chair Stand
Time frame: Baseline
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
30-Second Chair Stand
Time frame: 6 weeks
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
30-Second Chair Stand
Time frame: 12 weeks
Leg strength and endurance test - number of chair stand repetitions in 30 seconds
Five Time Sit to Stand Test (5TSTS)
Time frame: Baseline
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.
Five Time Sit to Stand Test (5TSTS)
Time frame: 6 weeks
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.
Five Time Sit to Stand Test (5TSTS)
Time frame: 12 weeks
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.
Single Leg Stance Test (SLS)
Time frame: 12 weeks
Assessment of static postural and balance control.
Functional limitations
Time frame: 12 weeks
Physical Functioning Questionnaire from the National Health and Nutrition Examination Survey
Falls
Time frame: 12 weeks
Falls over the past 3 months will be assessed using the Behavioral Risk Factor Surveillance System survey.
6 secondary outcomes
Walking gait cadence
Time frame: 10 day period pre and post intervention
Pain on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Time frame: 12 weeks
Fatigue on the Patient Reported Outcomes Measurement Information System (PROMIS) survey
Time frame: 12 weeks
Self-Efficay for Physical Activity (SEPA)
Time frame: 12 weeks
Percent of sessions attended
Time frame: 12 weeks
Heart rate
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 41818188Dandekar S, Kurth J, Shang Y, Stine JG, Ladwig MA, Conroy DE, Schmitz KH, Rovniak LS, Silvis M, Danilovich M, Ballentine N, Pierwola-Gawin N, Zhou S, Sciamanna C. Brief daily functional strength training to improve functional performance in older adults with mobility disability: A randomized trial. PLoS One. 2026 Mar 12;21(3):e0336748. doi: 10.1371/journal.pone.0336748. eCollection 2026.
Related trials for Walking, Difficulty
Active, not recruiting
Randomized Clinical Trial to Improve Mobility After Hospitalization
Hypertension, Diabetes
Active, not recruiting
Testing Interventions for Mobility Through Exercise (TIME)
Walking, Difficulty, Mobility Limitation
Not yet recruiting
Impact of Loss Aversion Messaging and Anticipated Regret for Inaction on Exercise Adherence in Older Adults
Mobility Disability, Walking Difficulty
RecruitingPhase 2
Response to Exercise and Nitric Oxide in PAD
Peripheral Artery Disease, Exercise
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily exercise intervention in people with Walking, Difficulty, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Second Chair Stand (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.