Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis

NCT00956488 | Completed Phase 1

• 1 other identifier: 07-08-15E
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if supervised exercise training using a treadmill with partial weight support is safe and has an impact on gait and function of persons with Amyotrophic lateral sclerosis.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Lou Gehrig's Disease

Keywords

Exercise for Amyotrophic lateral sclerosis

Outcome Measures

Primary Outcomes (3)

• Twenty Five Foot Walk Test (25FWT)

  baseline, after 4 weaks and 8 weaks post training

• The Six-Minute Walk Test (6MWT)

  baseline, after 4 weaks and 8 weaks post training

• Fatigue severity scale (FSS)

  baseline, after 4 weaks and 8 weaks post training

Secondary Outcomes (4)

• Muscle strength

  baseline, after 4 weaks and 8 weaks post training

• ALS functional rating scale (ALSFRS-R)

  baseline, after 4 weaks and 8 weaks post training

• Vital Capacity

  baseline, after 4 weaks and 8 weaks post training

• Beck Depression Inventory (BDI)

  baseline, after 4 weaks and 8 weaks post training

Study Arms (1)

supported treadmill ambulation training

EXPERIMENTAL

Behavioral: Treadmill Exercise

Interventions

Treadmill Exercise BEHAVIORAL

The intervention will consist of 30 minutes of exercise, performed 3 times per week for 8 weeks (24 sessions). Patient will walk on a treadmill with up to 40% of their body weight supported by a body weight support system with an overhead harness. The training session duration will be 60 minutes consisting of six intervals of 5 minutes exercise, interspersed with 6 intervals of 5 minutes rest to avoid overwork weakness and fatigue. Five minute exercise intervals should be sufficient for patients to reach a steady state. Patients will build up their endurance to this training level at their own pace as tolerated. Walking speed will be determined as tolerated by each patient. Exercise intensity will be guided by each patient's own perception of exertion, but not to exceed level 12-13 (mild to moderate) on the modified Borg perceived exertion scale, and by oxygen saturation (Sa O2) ≥ 90% monitor by handheld pulse Oximeter.

supported treadmill ambulation training

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically probable or definite diagnosis of ALS/MND
• Able to stand independently and ambulate for six minutes with their assistive devices
• Able to complete the 25 foot walk in less than 1 minute
• Vital Capacity of over 65% predicted
• to 75 years of age
• Not a pregnant woman
• Able to provide informed consent and to comply with training and assessment procedures

You may not qualify if:

• Unstable angina or severe left main coronary disease
• End-stage congestive heart failure
• Severe valvular heart disease
• Malignant or unstable arrhythmias
• Elevated resting blood pressure (systolic, 200mmHg; diastolic, 110mmHg)
• Large or expanding aortic aneurysm
• Known cerebral aneurysm or recent intracranial bleed
• Uncontrolled or end-stage systemic disease
• Acute retinal hemorrhage or recent ophthalmologic surgery
• Acute or unstable musculoskeletal injury

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas ALS Clinical Resarch Center

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 21, 2022

Record last verified: 2013-07

Locations

US (1)