AgingNCT06353438
Hydraulic Resistance and Older Adults
A study testing Exercise Program in people with Aging and Fall, run by College of Staten Island, the City University of New York at 1 site in United States.
Trial summary
The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Fall, Old Age; Debility
- What is being tested?
- Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Dec 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Age 60+
Who cannot join
- Age <60
- Neurological condition
- Surgery within last 6 months
- Current injury
- Inability to follow directions
- Inability to participate in physical activity for any medical reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Bay Ridge Center
Brooklyn, New York, 11209
Mary Ann Coughlin, 718-306-2924, mcoughlin@bayridgecenter.org
About this study
Official title: Implementation of a Community Based Exercise Program for Older Adults Using Hydraulic Resistance Equipment
The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:
- Does the use of hydraulic exercise equipment decrease fall risk in older adults?
- Does the use of hydraulic exercise equipment improve function in older adults?
Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).
- Conditions
- Aging, Fall, Old Age; Debility, Muscle Weakness
- Being tested
- Exercise Program
- Medical subject headings
- Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
Concentric strengthening of multiple muscle groups 2x/week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All subjects will participate in a 2x/week for 6 weeks exercise program using Frei FACTUM® novus II line exercise equipment, which uses hydraulic resistance. Each session will take 30-45 minutes to complete. The equipment uses concentric movements only but works both agonist and antagonist muscles with each piece of equipment (IE: push and pull). Participants results will be compared pre and post intervention. Receives: Other: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Objective functional outcome measure that assesses fall risk. Participants will move through 14 different tasks and will be assessed on their performance on a 0-4 scale. The higher the number given for a task, the better the participant's balance. The highest possible score is 56, which indicates low fall risk. The lower the score, the higher the fall risk. Minimal detectable change ranges from 5-7 depending on the diagnosis of the patient.
Measured: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Timed Up and Go
Objective functional outcome measure that assesses fall risk. Participants will start seated in a chair. When the assessor says "Go" the participant will stand up from the chair, walk 3 meters or 10 feet, turn around and walk back to the chair and sit down. The assessor will use a stopwatch to measure how much time it takes to complete this task. A score of 12 seconds or more indicates increased fall risk.
Measured: 1 week prior to 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test) start date and 1 week post intervention end date
Tinetti Balance and Gait Assessment Tool
Objective functional outcome measure that assesses fall risk. This test looks at 9 different balance tasks (sitting balance, sit to stand, standing balance, for example) and 7 domains during gait (hesitancy to begin walking, step length and height, step symmetry, step continuity, for example). Balance score is out of 16 and gait score is out of 12. Total score is out of 28. The lower the score, the higher the fall risk.
Measured: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Lower Extremity Functional Scale
Objective functional outcome measure that determines functional ability during lower extremity tasks. Subjects rate their ability to perform 20 different lower extremity tasks on a 0-4 scale (0 is unable to complete activity and 4 is no difficulty). Scores range from 0-80. A total score of 80 means no difficulty with any task listed. 0 means unable to perform any task listed. The minimum clinically important difference (MCID) for the Lower Extremity Functional Scale is 9 points.
Measured: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Secondary outcomes (1)
Strength
Participant strength will be measured using the exercise equipment (FREI-Swiss Factum Line). Participants will perform maximal voluntary isometric contractions (MVIC) for each muscle group on each piece of exercise equipment for agonist and antagonist muscles. This strength testing will determine how much resistance will be provided during the intervention; the exercise equipment uses a specific algorithm to determine how much load will be provided. Each participant will be given a unique card to "log in" to the equipment during each session and it will keep note of their scores and performance on each piece of equipment. The MVIC will take place pre and post intervention.
Measured: 1 week prior to intervention start date and 1 week post intervention end date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Staten Island, the City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Bay Ridge Center
- Responsible party
- Sponsor
- Investigators
- Amanda L Rotondo, DPT, Principal investigator, CUNY College of Staten Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353438
- Sponsor's protocol ID
- 2024XXXX
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be 1 PI and 5 co-investigators for this study. Data will be shared with those involved for data analysis purposes. Data will be stored in the PI's locked office in a locked filing cabinet and on a password protected computer owned by the PI.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Community Based Exercise Program for Older Adults Using Hydraulic Resistance Equipment
- ClinicalTrials.gov ID
- NCT06353438
- Acronym / sponsor ID
- 2024XXXX
- Conditions
- Aging, Fall, Old Age; Debility, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- College of Staten Island, the City University of New YorkUniversity, hospital or other
- Collaborators
- Bay Ridge Center
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Apr 2024 (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.
The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:
- Does the use of hydraulic exercise equipment decrease fall risk in older adults?
- Does the use of hydraulic exercise equipment improve function in older adults?
Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Exercise ProgramAll subjects will participate in a 2x/week for 6 weeks exercise program using Frei FACTUM® novus II line exercise equipment, which uses hydraulic resistance. Each session will take 30-45 minutes to complete. The equipment uses concentric movements only but works both agonist and antagonist muscles with each piece of equipment (IE: push and pull). Participants results will be compared pre and post intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- Age 60+
Key exclusion criteria (6 listed)
- Age <60
- Neurological condition
- Surgery within last 6 months
- Current injury
- Inability to follow directions
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 |
|---|---|---|
| Exercise ProgramConcentric strengthening of multiple muscle groups 2x/week for 6 weeks. | Other | Intervention |
Primary outcome
Berg Balance Scale
Time frame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Objective functional outcome measure that assesses fall risk. Participants will move through 14 different tasks and will be assessed on their performance on a 0-4 scale. The higher the number given for a task, the better the participant's balance. The highest possible score is 56, which indicates low fall risk. The lower the score, the higher the fall risk. Minimal detectable change ranges from 5-7 depending on the diagnosis of the patient.
Timed Up and Go
Time frame: 1 week prior to 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test) start date and 1 week post intervention end date
Objective functional outcome measure that assesses fall risk. Participants will start seated in a chair. When the assessor says "Go" the participant will stand up from the chair, walk 3 meters or 10 feet, turn around and walk back to the chair and sit down. The assessor will use a stopwatch to measure how much time it takes to complete this task. A score of 12 seconds or more indicates increased fall risk.
Tinetti Balance and Gait Assessment Tool
Time frame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Objective functional outcome measure that assesses fall risk. This test looks at 9 different balance tasks (sitting balance, sit to stand, standing balance, for example) and 7 domains during gait (hesitancy to begin walking, step length and height, step symmetry, step continuity, for example). Balance score is out of 16 and gait score is out of 12. Total score is out of 28. The lower the score, the higher the fall risk.
Lower Extremity Functional Scale
Time frame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)
Objective functional outcome measure that determines functional ability during lower extremity tasks. Subjects rate their ability to perform 20 different lower extremity tasks on a 0-4 scale (0 is unable to complete activity and 4 is no difficulty). Scores range from 0-80. A total score of 80 means no difficulty with any task listed. 0 means unable to perform any task listed. The minimum clinically important difference (MCID) for the Lower Extremity Functional Scale is 9 points.
1 secondary outcome
Strength
Time frame: 1 week prior to intervention start date and 1 week post intervention end date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No. There will be 1 PI and 5 co-investigators for this study. Data will be shared with those involved for data analysis purposes. Data will be stored in the PI's locked office in a locked filing cabinet and on a password protected computer owned by the PI.
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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.
Amanda L Rotondo, DPT principal investigator
CUNY College of Staten Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Aging and Fall, run by College of Staten Island, the City University of New York 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda L Rotondo, DPT (9179912709, amanda.rotondo@csi.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2024.