Skip to content

Quality of Life and Rehabilitation Care in Amyotrofic Lateral Sclerosis.

Quality of Life and Rehabilitation Care in Amyotrofic Lateral Sclerosis. - FACTS-2-ALS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39262
Enrollment
80
Registered
2009-07-21
Start date
2010-02-26
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis muscular disease neuromuscular disease

Interventions

The 80 patients will be randomized to one of two groups i.e. (1) aerobe exercise therapy (AET) + usual care. AET consist of aerobic exercises for a period of 16 weeks, 3 days a week, twice at home a

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years 2. A life-expectancy longer than one year 3. Forced Vital Capacity at least 80% 4. Diagnosis of "Probable" or "definite" ALS according to the "revised El Escorial WFN criteria" 5. At least 1 month post-diagnosis ALS 6. Being in the rehabilitation phase; diagnotic phase is completed. 7. Walking-ability with or without a ankle-foot orthotic or stick and cycling-ability on a bicycle ergometer, in that capacity that the intervention is expected to be completed.

Exclusion criteria

Exclusion criteria: 1. Cognitive impairment 2. Insufficient mastery of the Dutch language 3. Disabling co-morbidity interfering with the intervention programs or influencing outcome parameters (including severe cardiopulmonair disease, like chest pain, arrhytmia, pacemaker, cardiac surgery, sever dyspnoea d'effort or emphysema, epileptic seizures, poorly regulted diabetes mellitus or hypertension. 4. Psychological disorder, in that capacity that the intervention could not be completed.

Design outcomes

Primary

MeasureTime frame
Quality of life (ALSAQ-40, SF-36), activities (LAPAQ, IPA)

Secondary

MeasureTime frame
Functional capacity. Patients*, partners* and professionals* expectations of and experiences with the AET intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)