TY - JOUR
T1 - A randomized controlled trial of resistance and endurance exercise in amyotrophic lateral sclerosis
AU - On behalf of the neals consortium
AU - Clawson, Lora L.
AU - Cudkowicz, Merit
AU - Krivickas, Lisa
AU - Brooks, Benjamin R.
AU - Sanjak, Mohammed
AU - Allred, Peggy
AU - Atassi, Nazem
AU - Swartz, Amy
AU - Steinhorn, Gabrielle
AU - Uchil, Alpa
AU - Riley, Kristen M.
AU - Yu, Hong
AU - Schoenfeld, David A.
AU - Maragakis, Nicholas J.
N1 - Funding Information:
This study was funded by the ALS Association Grant #1489 as well as the William Gray Smith Fund at Johns Hopkins. Co-investigators and Northeast ALS Consortium: Vanina Dal Bello Haas (McMaster University, Advisor), Julaine Florence (Washington University, Advisor), and Mark Tarnopolsky (McMaster University, Advisor). The Northeast ALS Consortium: Robert Baloh (Cedars Sinai, Site Investigator), James Berry (Massachusetts General Hospital, Site Investigator), Richard Lewis (Cedars Sinai Medical Center, Site Investigator), Elizabeth Mosmiller (Johns Hopkins University, Clinical Evaluator), Kelly Casey (Johns Hopkins University, Occupational Therapist), Amy Swartz Ellrodt (Massachusetts General Hospital, Study Coordinator & Physical Therapist), Owen O’Connor (Massachusetts General Hospital, Study Coordinator) Kellen Haley (Massachusetts General Hospital, Study Coordinator), Pat Andres (Massachusetts General Hospital, Physical Therapist), Cynthia Lary (Carolinas Medical Center, Study Coordinator), Scott Holsten (Carolinas Medical Center, Clinical Evaluator), K. Ashley Fetterman (Cedars-Sinai Medical Center, Study Coordinator). Erik Pioro (Cleveland Clinic, Data and Safety Monitor), Haining Li (Massachusetts General Hospital, Data Management), K. Jane Barkan (Barrows Neurological Institute, Site Monitor), Jeremy Shefner (Barrows Neurological Institute, Director of Site Monitoring).
Funding Information:
This study was funded by the ALS Association Grant #1489 as well as the William Gray Smith Fund at Johns Hopkins.
Publisher Copyright:
© 2017 World Federation of Neurology on behalf of the Research Group on Motor Neuron Diseases.
PY - 2018/4/3
Y1 - 2018/4/3
N2 - Objective: Evaluate the safety and tolerability of resistance and endurance exercise in ALS participants as measured by their ability to complete this six-month study. Methods: Participants were randomized to Resistance, Endurance, or Stretching/Range of Motion (SROM the exercise regimen prescribed for most ALS patients) exercises. All exercises were performed at home with an individualized regimen designed by a physical therapist trained in ALS management. Primary outcome measures were tolerability of the exercises at 24 weeks defined by 50% of participants completing at least 50% of the prescribed exercise regimen. Secondary outcome measures included the ALSFRS-R, pulmonary FVC, and other measures of ALS function. Results: At 12 and 24 weeks, all three exercise regimens were tolerated according to our pre-specified criteria. Compliance to the prescribed exercise regimen was the highest in the resistance and SROM arms of the study. All three forms of exercise were considered safe as there were no differences in the rates of disease progression among groups. There were no differences in the secondary outcome measures and feasibility for evaluating these measures was successful. In a post-hoc analysis, there was a trend towards fewer falls in the Resistance and Endurance groups. Conclusions: This study demonstrates that SROM, resistance, and endurance exercise are all safe to be performed with the specified regimen without any worsening of outcomes as related to ALS function. All three forms of exercise were tolerated with resistance and SROM exercises showing the highest compliance over the 24 week-period.
AB - Objective: Evaluate the safety and tolerability of resistance and endurance exercise in ALS participants as measured by their ability to complete this six-month study. Methods: Participants were randomized to Resistance, Endurance, or Stretching/Range of Motion (SROM the exercise regimen prescribed for most ALS patients) exercises. All exercises were performed at home with an individualized regimen designed by a physical therapist trained in ALS management. Primary outcome measures were tolerability of the exercises at 24 weeks defined by 50% of participants completing at least 50% of the prescribed exercise regimen. Secondary outcome measures included the ALSFRS-R, pulmonary FVC, and other measures of ALS function. Results: At 12 and 24 weeks, all three exercise regimens were tolerated according to our pre-specified criteria. Compliance to the prescribed exercise regimen was the highest in the resistance and SROM arms of the study. All three forms of exercise were considered safe as there were no differences in the rates of disease progression among groups. There were no differences in the secondary outcome measures and feasibility for evaluating these measures was successful. In a post-hoc analysis, there was a trend towards fewer falls in the Resistance and Endurance groups. Conclusions: This study demonstrates that SROM, resistance, and endurance exercise are all safe to be performed with the specified regimen without any worsening of outcomes as related to ALS function. All three forms of exercise were tolerated with resistance and SROM exercises showing the highest compliance over the 24 week-period.
KW - ALS
KW - benefit
KW - clinical trial
KW - motor neuron disease
KW - tolerability
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U2 - 10.1080/21678421.2017.1404108
DO - 10.1080/21678421.2017.1404108
M3 - Article
C2 - 29191052
AN - SCOPUS:85035757147
SN - 2167-8421
VL - 19
SP - 250
EP - 258
JO - Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
JF - Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
IS - 3-4
ER -