NCT02895789|Completed
Oxidative Capacity and Exercise Tolerance in Ambulatory SMA
Evaluation of Oxidative Capacity and Exercise Tolerance in Ambulatory Patients With Spinal Muscular Atrophy (SMA)
Loading search results
Evaluation of Oxidative Capacity and Exercise Tolerance in Ambulatory Patients With Spinal Muscular Atrophy (SMA)
Sponsor study identifier
Secondary identifiers
observational
42
1 country
1
Study Start
November 2016
Actual (reported)Primary Completion
October 2020
Actual (reported)Study Completion
January 2021
Actual (reported)This proposal will focus on (1) estimating oxidative capacity of specific muscle groups during exercise using near infrared spectroscopy and (2) describing body composition to better understand exercise capacity and mitochondrial function in ambulatory spinal muscular atrophy (SMA) patients and disease controls. It is a 6-month observational study including 14 ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2016
Actual (reported)September 12, 2016
Actual (reported)November 2016
Actual (reported)October 2020
Actual (reported)January 2021
Actual (reported)Change in NIRS derived index of muscle oxygen extraction
Near Infrared Spectroscopy (NIRS) is a simple, non-invasive method to measure oxygen in muscle and other tissues in vivo.
baseline, 6 months
Change in Peak oxygen uptake (V02 max)
baseline, 6 months
Change in Distance walked during the Six Minute Walk Test (6MWT)
baseline, 6 months
ambulatory children and adults ages between 8 and 55 years old by the time of enrollment with laboratory documentation of homozygous deletion of SMN1 exon 7
ambulatory children and adults ages between 8 and 55 years old by the time of enrollment with genetic confirmation or evidence from muscle biopsy confirming the diagnosis
The healthy control group will be age and gender-matched to the SMA and mitochondrial myopathy groups as best as possible.
The study sample will include 14 ambulatory SMA patients, 14 ambulatory mitochondrial myopathy patients, and 14 healthy controls.
Columbia University Medical Center
New York, New York, 10032, United States
Jacqueline Montes, PT, EdD
Columbia University
42 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2016
First Posted
September 12, 2016
Study Start
November 2016
Actual (reported)The Effects of Exercise Versus Inactivity on People With Mitochondrial Muscle Disease
Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3
Change in Lean body mass assessed with Dual Energy X-ray Absorptiometry (DEXA)
baseline, 6 months
Contact the study team to confirm eligibility.
Primary Completion
October 2020
Actual (reported)Study Completion
January 2021
Actual (reported)Last Updated
March 8, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: