Hydraulic Resistance and Older Adults

NCT06353438 | Not Yet Recruiting

• 1 other identifier: 2024XXXX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  1 week prior to intervention start date (pre-test) and 1 week post intervention end date (post-test)

Secondary Outcomes (1)

• Strength

  1 week prior to intervention start date and 1 week post intervention end date

Study Arms (1)

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.

Other: Exercise Program

Interventions

Exercise Program OTHER

Concentric strengthening of multiple muscle groups 2x/week for 6 weeks.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Age 60+

You may not qualify if:

• 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

Sponsors & Collaborators

• College of Staten Island, the City University of New York: lead
• Bay Ridge Center: collaborator

Study Sites (1)

Bay Ridge Center

Brooklyn, New York, 11209, United States

Location

MeSH Terms

Conditions

Frailty; Muscle Weakness

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amanda L Rotondo, DPT

  CUNY College of Staten Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda L Rotondo, DPT

CONTACT

9179912709; amanda.rotondo@csi.cuny.edu

Study Design

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

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 9, 2024
• Study Start: May 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)