Amyotrophic Lateral SclerosisPhase 1/2NCT00956488
Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
A Phase 1/2 study testing Treadmill Exercise in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Lou Gehrig's Disease
- What is being tested?
- Treadmill Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas ALS Clinical Resarch Center
Charlotte, North Carolina, 28207
About this study
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.
Read the 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.
- Being tested
- Treadmill Exercise
- Keywords
- Exercise for Amyotrophic lateral sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| supported treadmill ambulation training | Experimental | Not described Receives: Behavioral: Treadmill Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twenty Five Foot Walk Test (25FWT)
Measured: baseline, after 4 weaks and 8 weaks post training
The Six-Minute Walk Test (6MWT)
Measured: baseline, after 4 weaks and 8 weaks post training
Fatigue severity scale (FSS)
Measured: baseline, after 4 weaks and 8 weaks post training
Secondary outcomes (4)
Muscle strength
Measured: baseline, after 4 weaks and 8 weaks post training
ALS functional rating scale (ALSFRS-R)
Measured: baseline, after 4 weaks and 8 weaks post training
Vital Capacity
Measured: baseline, after 4 weaks and 8 weaks post training
Beck Depression Inventory (BDI)
Measured: baseline, after 4 weaks and 8 weaks post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956488
- Sponsor's protocol ID
- 07-08-15E
- Status last verified
- Jul 2013
- First submitted
- 10 Aug 2009
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
- ClinicalTrials.gov ID
- NCT00956488
- Acronym / sponsor ID
- 07-08-15E
- Keywords
- Exercise for Amyotrophic lateral sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| supported treadmill ambulation training | Experimental | Behavioral: Treadmill Exercise |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill ExerciseThe 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. | Behavioural | supported treadmill ambulation training |
Primary outcome
Twenty Five Foot Walk Test (25FWT)
Time frame: baseline, after 4 weaks and 8 weaks post training
The Six-Minute Walk Test (6MWT)
Time frame: baseline, after 4 weaks and 8 weaks post training
Fatigue severity scale (FSS)
Time frame: baseline, after 4 weaks and 8 weaks post training
4 secondary outcomes
Muscle strength
Time frame: baseline, after 4 weaks and 8 weaks post training
ALS functional rating scale (ALSFRS-R)
Time frame: baseline, after 4 weaks and 8 weaks post training
Vital Capacity
Time frame: baseline, after 4 weaks and 8 weaks post training
Beck Depression Inventory (BDI)
Time frame: baseline, after 4 weaks and 8 weaks post training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Treadmill Exercise in people with Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twenty Five Foot Walk Test (25FWT) (time frame: baseline, after 4 weaks and 8 weaks post training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.