Testing the Dose-response of Coordination Training for Older Adults.

NCT03629730 | Completed

• 1 other identifier: STU 082017-078
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

There is an urgent need for interventions to reduce mobility limitations that affect over 15 million older adults and contribute to falls, disability, hospitalization and death. This training will give Dr. James the skills to become an independent researcher developing interventions to decrease mobility limitations, disability and falls in older adults. His multidisciplinary mentorship team, led by Kathleen Bell, MD, has extensive experience with externally sponsored research, expertise in the targeted training domains, mentoring new investigators, and is highly committed to Dr. James' development as a researcher. Dr. James has identified novel impairments in rhythmic interlimb and gait coordination as strongly linked to mobility among community-dwelling older adults. Currently, no treatment for limb coordination exists. In an effort to advance the development of treatments for mobility limitations, the objective of the proposed research is to examine the dose-response of an innovative intervention to improve coordination in community-dwelling older adults with mobility limitations. The intervention uses a metronome to retrain coordination impairments that develop with age, and consists of practice improving the coordination of the right and left: a) ankles; b) shoulders; and c) ankles and shoulders, while lying supine, and d) the arms and legs during walking; by synchronizing movements with a metronome. This project is significant in that the approach may offer a cost-effective, clinically applicable, and efficacious means of reducing mobility limitations in older adults. We will initially refine the intervention, and subsequently conduct a randomized trial of 2-, 4- and 8-week intervention treatments vs. physical activity control with (N=120) community-dwelling older adults aged \>70 years with mobility limitations. These treatment durations correspond to what rehabilitative care providers would consider a short vs. medium vs. long duration (dose) of treatment. We will examine the magnitude and duration of change in interlimb ankle coordination and gait coordination for each group. We will estimate the coordination effect sizes for a minimal clinically important difference in mobility performance, and explore changes in upper limb coordination and performance-based and self-reported mobility.

Conditions

Mobility Limitation

Keywords

coordination

Outcome Measures

Primary Outcomes (2)

• Ankle coordination variability

  Change in the standard deviation of the relative phase between the ankles during rhythmic antiphase coordination synchronizing with a metronome.

  Every 2 weeks from baseline until 8 weeks post-intervention.

• Gait coordination

  Change in the Phase Coordination Index of the right-left stepping pattern during normal pace walking.

  Every 2 weeks from baseline until 8 weeks post-interention.

Secondary Outcomes (2)

• Short Physical Performance Battery

  Every 2 weeks from baseline until 8 weeks post-intervention.

• Shoulder coordination variability

  Every 2 weeks from baseline until 8 weeks post-intervention.

Study Arms (4)

High dose

EXPERIMENTAL

Will receive the greatest duration of coordination intervention training.

Behavioral: Coordination training

Intermediate dose

EXPERIMENTAL

Will receive a moderate duration of coordination intervention training.

Behavioral: Coordination training

Low dose

EXPERIMENTAL

Will receive a short duration of coordination intervention training.

Behavioral: Coordination training

Active control

ACTIVE COMPARATOR

Will perform the same number and duration of physical exercises as the High Dose group, but while moving one body segment at a time.

Behavioral: Coordination training

Interventions

Coordination training BEHAVIORAL

The intervention will consist of 8 weeks of exercises to decrease the variability of participants' body and gait coordination. The intervention will consist of 1 training session /week in the Mobility Research Laboratory and 4 days of home-based training. In each session participants will perform 6 trials of 4 body coordination exercises and 1 gait exercise. In the intervention sessions participants will perform interlimb coordination exercises, synchronizing body segments with auditory metronome tones. Participants also will perform a gait exercise by synchronizing steps with an auditory metronome during walking. The metronome will assist participants to retrain their movement timing to decrease coordination variability.

Active control; High dose; Intermediate dose; Low dose

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 70 years or older
• Walk 20 feet without personal assistance
• Sufficient vision to read written materials
• Sufficient hearing to synchronize movements with auditory metronome tones.

You may not qualify if:

• Severe language, visual, or hearing deficits
• Inability to perform the intervention exercises
• Self-report of:
• A diagnosis or prescription of medications consistent with any psychiatric disorder Parkinson's disease Alzheimer's disease Stroke Severe head injury in the last two years A history of cardiovascular disease Having a terminal disease Major surgery or myocardial infarction in the past 6 months Planned major surgery Major medical problems interfering with safe and successful balance and walking Inability to read, speak and understand English Plan to leave the area within the next 1 year. Chronic pain that interferes with walking or standing
• Mini-Mental State Examination score \<18

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Principal Investigator and Research Coordinators conducting participant assessments will be masked as to participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three intervention dose groups and one active control group will be compared.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: March 15, 2019
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)