Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial

Annerieke C van Groenestijn; Carin D Schröder; Ruben P A van Eijk; Jan H Veldink; Esther T Kruitwagen-van Reenen; Jan T Groothuis; Hepke F Grupstra; Marga Tepper; Reinout O van Vliet; Johanna M A Visser-Meily; Leonard H van den Berg

doi:10.1177/1545968319826051

Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial

Annerieke C van Groenestijn
, Carin D Schröder
, Ruben P A van Eijk
, Jan H Veldink
, Esther T Kruitwagen-van Reenen
, Jan T Groothuis
, Hepke F Grupstra
, Marga Tepper
, Reinout O van Vliet
, Johanna M A Visser-Meily
, Leonard H van den Berg

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	153-164
Number of pages	12
Journal	Neurorehabilitation and Neural Repair
Volume	33
Issue number	2
DOIs	https://doi.org/10.1177/1545968319826051
Publication status	Published - 1 Feb 2019

Keywords

amyotrophic lateral sclerosis
exercise
quality of life
randomized controlled trial
respiratory function tests

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groenestijnFinal published version, 315 KBLicence: Taverne

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van Groenestijn, A. C., Schröder, C. D., van Eijk, R. P. A., Veldink, J. H., Kruitwagen-van Reenen, E. T., Groothuis, J. T., Grupstra, H. F., Tepper, M., van Vliet, R. O., Visser-Meily, J. M. A., & van den Berg, L. H. (2019). Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial. Neurorehabilitation and Neural Repair, 33(2), 153-164. https://doi.org/10.1177/1545968319826051

@article{da520af678ec46b69dfef9dfc5221557,

title = "Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial",

abstract = "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.",

keywords = "amyotrophic lateral sclerosis, exercise, quality of life, randomized controlled trial, respiratory function tests",

author = "\{van Groenestijn\}, \{Annerieke C\} and Schr{\"o}der, \{Carin D\} and \{van Eijk\}, \{Ruben P A\} and Veldink, \{Jan H\} and \{Kruitwagen-van Reenen\}, \{Esther T\} and Groothuis, \{Jan T\} and Grupstra, \{Hepke F\} and Marga Tepper and \{van Vliet\}, \{Reinout O\} and Visser-Meily, \{Johanna M A\} and \{van den Berg\}, \{Leonard H\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2019.",

year = "2019",

month = feb,

day = "1",

doi = "10.1177/1545968319826051",

language = "English",

volume = "33",

pages = "153--164",

journal = "Neurorehabilitation and Neural Repair",

issn = "1545-9683",

publisher = "SAGE Publications Inc.",

number = "2",

}

van Groenestijn, AC, Schröder, CD, van Eijk, RPA , Veldink, JH, Kruitwagen-van Reenen, ET, Groothuis, JT, Grupstra, HF, Tepper, M, van Vliet, RO, Visser-Meily, JMA & van den Berg, LH 2019, 'Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial', Neurorehabilitation and Neural Repair, vol. 33, no. 2, pp. 153-164. https://doi.org/10.1177/1545968319826051

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 - 2019/2/1

Y1 - 2019/2/1

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

KW - exercise

KW - quality of life

KW - randomized controlled trial

KW - respiratory function tests

UR - https://www.scopus.com/pages/publications/85061372798

U2 - 10.1177/1545968319826051

DO - 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 -

Aerobic Exercise Therapy in Ambulatory Patients With ALS: A Randomized Controlled Trial

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