Low intensity exercise training in patients with amyotrophic lateral sclerosis – factors influencing eligibility and compliance to the clinical trial

ABSTRACT

Background

To date, there are no evidence-based recommendations for physical therapy in amyotrophic lateral sclerosis (ALS). The reason is a low number of related clinical trials (CTs), restricted sample sizes and a high dropout rate. It may influence the profile of the participants, while the final results might not translate to the general ALS population.

Objective

To analyze factors affecting the ALS patients’ enrollment and retention to the study, and to describe a profile of participants as compared to the eligible group.

Methods

A total of 104 ALS patients were offered participation in a CT of low-intensity exercises at home. Forty-six patients were recruited. Demographic and clinical data (El Escorial criteria, site of onset, diagnosis delay, disease duration, amyotrophic lateral sclerosis functional rating scale – revised [ALSFRS-R], Medical Research Council [MRC], hand-held dynamometry) were analyzed every 3 months.

Results

Male gender, younger age and a higher ALSFRS predicted enrollment, while male gender, higher ALSFRS-R and MRC predicted retention in the study. A long commute to the study site and a fast disease progression were the main reasons influencing both enrollment and retention. Despite a high dropout rate, study participants were representative for the general ALS population.

Conclusion

The above demographic, clinical and logistic factors need to be considered when designing studies in ALS population.

KEYWORDS:

• Exercise
• amyotrophic lateral sclerosis
• eligibility
• compliance
• physical therapy

Acknowledgments

The authors wish to thank the patients and their families for active participation in the study. This work was funded by the JPND (NEEDSinALS; www.NEEDSinALS.com). This is an EU Joint Programme – Neurodegenerative Disease Research (JPND; 01ED1405) project. The project is supported through the following organizations under the aegis of JPND – www.jpnd.eu, e.g. Germany, Bundesministerium für Bildung und Forschung (BMBF, FKZ), Sweden, Vetenskapr å det Sverige, and Poland, Narodowe Centrum Badan i Rozwoju (NCBR).

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The work was supported by the EU Joint Programme – Neurodegenerative Disease Research [01ED1405].