Comparison of Two Exercise Interventions to Improve Gait in Older Persons

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. The investigators want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength.

Detailed Description
-----------------
The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. We want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength. Adults aged 65 years or older, who are able to walk without the help of another person, are being asked to participate. If you are able to walk independently and you have medical clearance from your physician to participate in activities requiring low to moderate physical activity, you are invited to participate. We plan to enroll 40 older adults, all who have small problems with walking due to balance or strength, in this research study.

Official Title
-----------------
Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study

Conditions
-----------------
Gait

Intervention / Treatment
-----------------
* Behavioral: skill based exercise
* Behavioral: aerobic conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years of age and older Ambulatory without an assistive device or the assistance of another person Usual 4 meter gait speed ≥1.0 m/s Completes a figure-of-eight walk in > 8.0 seconds Exclusion Criteria: Inability to participate in testing: persistent lower extremity pain that is present on most days of the week and crepitus, tenderness or enlargement of joints of the lower extremity (arthritis).84 back pain that is present on most days of the weeks and interferes with walking and activities of daily living or back pain that increases with walking (lumbar stenosis) calf pain or cramping which worsens with walking and is relieved by rest (PAD) refusal to walk on a treadmill Safety concerns: dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD) any acute illness or medical condition that is not stable according to the approving physician resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute85 diagnosed dementia or cognitive impairment defined as a MMSE score < 24 hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures severe visual impairment with visual acuity < 20/70 with best correction history of stroke fixed or fused lower extremity joints such as hip, knee or ankle lower extremity strength <4/5 on manual muscle testing lower extremity amputation progressive movement disorder such as MS, ALS or Parkinson's disease

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skill-based exercise<br>2 times per week for 12 weeks. warm-up, stretching, strengthening, and skill-based exercises. Pre-gait and gait activities including stepping patterns and walking patterns and treadmill training at various walking speeds | Behavioral: skill based exercise<br>* 2 times per week for 12 weeks Pre gait and gait activities<br>|
| Active Comparator: aerobic exercise training<br>warm-up, strengthening and aerobic conditioning (treadmill walking) | Behavioral: aerobic conditioning<br>* 2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait | gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8 | 12 weeks | 
| Physical function | LLFDI function and disability scales | 12 weeks | 
| Physical Activity | Actigraph accelerometer | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability and health care costs | Late Life Function and disability index, fall history and health care cost questionnaire will be administered through a phone interview 6 months following completion of the exercise program | 6 months post exercise | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gait, exercise, skill-based, aerobic