TY - JOUR
T1 - Aerobic Exercise Therapy in Ambulatory Patients With ALS
T2 - A Randomized Controlled Trial
AU - van Groenestijn, Annerieke C
AU - Schröder, Carin D
AU - van Eijk, Ruben P A
AU - Veldink, Jan H
AU - Kruitwagen-van Reenen, Esther T
AU - Groothuis, Jan T
AU - Grupstra, Hepke F
AU - Tepper, Marga
AU - van Vliet, Reinout O
AU - Visser-Meily, Johanna M A
AU - van den Berg, Leonard H
PY - 2019/2
Y1 - 2019/2
N2 - BACKGROUND: Weakness caused by motor neuron degeneration in amyotrophic lateral sclerosis (ALS) may result in avoidance of physical activity, resulting in deconditioning and reduced health-related quality of life (HRQoL).OBJECTIVE: To study the effectiveness of aerobic exercise therapy (AET) on disease-specific and generic HRQoL in ambulatory patients with ALS.METHODS: We conducted a multicenter, assessor-blinded, randomized controlled trial. Using a biphasic randomization model, ambulatory ALS patients were assigned (1:1) to AET+usual care (UC), or UC. AET consisted of a 16-week aerobic cycling exercise program. Primary outcome measures were the 40-item ALS assessment questionnaire (ALSAQ-40), and the mental component summary (MCS) and physical component summary (PCS) scores of the short-form survey (SF-36), using linear mixed effects models. Per-protocol (PP) analysis was performed for those patients who attended ≥75% of the training sessions; controls were matched (1:1) by propensity score matching.RESULTS: Of 325 screened patients, 57 were randomized: 27 to AET+UC and 30 to UC. No significant mean slope differences between groups were observed for ALSAQ-40 (-1.07; 95% confidence interval [CI] -2.6 to 0.5, P=0.172) nor for SF-36 MCS (0.24; -0.7 to 1.1, P=0.576) or PCS (-0.51; -1.4 to 0.38, P=0.263). There were no adverse events related to the AET. PP-analyses showed significantly less deterioration in ALSAQ-40 (-1.88, -3.8 to 0.0, P=0.046) in AET+UC compared to UC.CONCLUSIONS: AET+UC was not superior to UC alone in preserving HRQoL in ambulatory ALS patient. However, the study was unfortunately underpowered, because only 10 patients completed the protocol. AET+UC may preserve disease-specific HRQoL in slow progressors.CLINICAL TRIAL REGISTRATION NUMBER: Netherlands National Trial Register (NTR): 1616.
AB - BACKGROUND: Weakness caused by motor neuron degeneration in amyotrophic lateral sclerosis (ALS) may result in avoidance of physical activity, resulting in deconditioning and reduced health-related quality of life (HRQoL).OBJECTIVE: To study the effectiveness of aerobic exercise therapy (AET) on disease-specific and generic HRQoL in ambulatory patients with ALS.METHODS: We conducted a multicenter, assessor-blinded, randomized controlled trial. Using a biphasic randomization model, ambulatory ALS patients were assigned (1:1) to AET+usual care (UC), or UC. AET consisted of a 16-week aerobic cycling exercise program. Primary outcome measures were the 40-item ALS assessment questionnaire (ALSAQ-40), and the mental component summary (MCS) and physical component summary (PCS) scores of the short-form survey (SF-36), using linear mixed effects models. Per-protocol (PP) analysis was performed for those patients who attended ≥75% of the training sessions; controls were matched (1:1) by propensity score matching.RESULTS: Of 325 screened patients, 57 were randomized: 27 to AET+UC and 30 to UC. No significant mean slope differences between groups were observed for ALSAQ-40 (-1.07; 95% confidence interval [CI] -2.6 to 0.5, P=0.172) nor for SF-36 MCS (0.24; -0.7 to 1.1, P=0.576) or PCS (-0.51; -1.4 to 0.38, P=0.263). There were no adverse events related to the AET. PP-analyses showed significantly less deterioration in ALSAQ-40 (-1.88, -3.8 to 0.0, P=0.046) in AET+UC compared to UC.CONCLUSIONS: AET+UC was not superior to UC alone in preserving HRQoL in ambulatory ALS patient. However, the study was unfortunately underpowered, because only 10 patients completed the protocol. AET+UC may preserve disease-specific HRQoL in slow progressors.CLINICAL TRIAL REGISTRATION NUMBER: Netherlands National Trial Register (NTR): 1616.
KW - Amyotrophic Lateral Sclerosis/therapy
KW - Exercise Therapy
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Quality of Life
KW - Single-Blind Method
KW - Treatment Outcome
U2 - https://doi.org/10.1177/1545968319826051
DO - https://doi.org/10.1177/1545968319826051
M3 - Article
C2 - 30744529
SN - 1545-9683
VL - 33
SP - 153
EP - 164
JO - Neurorehabilitation and neural repair
JF - Neurorehabilitation and neural repair
IS - 2
ER -