Aerobic Training in Patients With Spinal Muscular Atrophy Type III

NCT02003937 | Completed DMC

• 1 other identifier: H-KF297836
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal muscular atrophy type III, (SMAIII) is a disease in the nerve cells in the spinal cord which leads to to progressive muscle weakness and atrophy. No effective treatment is available for SMA. We have previously shown that patients with muscular dystrophies improve oxidative capacity (VO2max), muscle strength and daily function by aerobic conditioning. Patients with SMAIII share many clinical features with these conditions, although the mechanism of muscle weakness is different. In this study, we investigated how patients with SMAIII respond to aerobic training. 6 patients and 9 healthy age- and sex-matched controls completed a 12 weeks training program. Subjects performed a total of 42 training session of 30 min on a stationary cycle ergometer at home. The work intensity was moderate and set to match a target heart rate. Training induced an increase without inducing muscle damage. However, training-induced fatigue was a major complaint in all patients, and caused one patient to drop out, increased the need for sleep in three patients and two had to modify the training program. The fatigue limits the use of this therapy. The training-induced fatigue, which is not encountered in muscle diseases, warrants investigations into alternative training methods to improve quality of life in patients with SMAIII.

Conditions

Spinal Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

• Changes in oxidative capacity with aerobic conditioning in SMAIII patients

  After 12 weeks of aerobic training

Secondary Outcomes (3)

• Changes in maximal workload capacity with aerobic conditioning in SMAIII patients

  After 12 weeks of aerobic conditioning

• Changes in isometric muscle strength with aerobic conditioning in SMAIII patients

  After 12 weeks of aerobic conditioning

• Changes in daily function with aerobic conditioning in SMAIII patients

  After 12 weeks of aerobic training

Study Arms (1)

12 weeks of aerobic conditioning

EXPERIMENTAL

12 weeks of aerobic conditioning, a total 42 sessions of 30min exercise on a stationary cycle ergometer

Behavioral: Aerobic conditioning

Interventions

Aerobic conditioning BEHAVIORAL

Subjects performed 12 weeks of aerobic training on a stationary cycle ergometer. Subjects compleeted a total of 42 training sessions of 30min. exercise at an individually adjusted moderate workload.

12 weeks of aerobic conditioning

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Genetically verified SMAIII

You may not qualify if:

• other serious medical conditions that could confound the interpretation of results and
• regular exercise more than one hour weekly

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Neuromuscular Research Unit, 3342

Copenhagen E, 2100, Denmark

Location

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Karen L Madsen, M.Sc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: December 6, 2013
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

DK (1)