Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammed Sanjak, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00956488
First received: August 10, 2009
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lou Gehrig's Disease
Behavioral: Treadmill Exercise
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Twenty Five Foot Walk Test (25FWT) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: No ]
  • The Six-Minute Walk Test (6MWT) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: No ]
  • Fatigue severity scale (FSS) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: Yes ]
  • ALS functional rating scale (ALSFRS-R) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: Yes ]
  • Vital Capacity [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: Yes ]
  • Beck Depression Inventory (BDI) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: supported treadmill ambulation training Behavioral: Treadmill Exercise
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.

Detailed Description:

Twenty ALS patients who are independent in their transfer with assistive devise such as walker, cane, or AFO will be offered the opportunity to participate in this study. 20 subjects will be enrolled at Carolinas ALS/Neuromuscular Center at the Carolinas HealthCare System. Eligible subjects will return for 26 sessions, each lasting between 1-2 hours. At Session 1 (4 weeks pre-treatment), assessments of muscle strength, spasticity, gait, and balance will be performed, which will take between 30-60 minutes. At Sessions 2-25, patients will do supported treadmill ambulation training at a very low speed 3 times a week for 6 weeks under the supervision of the physical therapist. Each session will have 30 minutes of direct ambulation with the suspension system and treadmill over a 60 minute period of time. Additionally, at sessions 13 and 26 (4 and 8 weeks post-treatment), the assessments of muscle strength, spasticity, gait, and balance will be repeated. Needle EMG to assess denervation potential will be performed at base line and at the conclusion of the study. The study will last a total of 26 weeks for each patient.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 25 to 75 years of age
  • Not a pregnant woman
  • Able to provide informed consent and to comply with training and assessment procedures

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956488

Locations
United States, North Carolina
Carolinas ALS Clinical Resarch Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: Mohammed Sanjak, Principle Invistigator, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00956488     History of Changes
Other Study ID Numbers: 07-08-15E
Study First Received: August 10, 2009
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Exercise for Amyotrophic lateral sclerosis

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on November 27, 2014