(1) To study the efficacy of AET for improving activities and QoL in patients with ALS. (2) To identify generic and disease-specific determinants of effects. (3) To obtain insight into patients* , partners* and professionals' expectations of…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life (ALSAQ-40, SF-36), activities (LAPAQ, IPA)
Secondary outcome
Functional capacity.
Patients*, partners* and professionals* expectations of and experiences with
the AET intervention.
Background summary
Amyotrophic lateral sclerosis (ALS) is a progressive, fatal disease,
characterised by loss of motor neurons in the cortex, brainstem, and spinal
cord. Patients have progressive wasting and weakness of limb, bulbar, and
respiratory muscles, and die on average within 3 years of symptom onset,
usually because of respiratory failure. Muscle weakness may result in the
avoidance of physical activity, which consequently enhance the disuse weakness
and cardiovascular deconditioning. The impact of the infaust prognosis may also
result in depressive symptoms and hopelessness and consequently in decline of
Quality of Life (QoL). Since ALS is not considered curable, rehabilitation
management is the mainstay of treatment. We hypothesize that to preserve daily
activity and Quality of Life on the highest achievable level, a therapeutic
intervention can be executed: aerobic exercise therapy (AET) to
maintain/enhance functional capacity in ALS-patients. However, evidence to
support this approach is still insufficient and understanding of the underlying
mechanisms of the approache is unclear. There is preliminary evidence for the
effectiveness of exercise in ALS. There is need for rigorous, appropriately
controlled assessment of the efficacy of this intervention for ALS patients.
Study objective
(1) To study the efficacy of AET for improving activities and QoL in patients
with ALS. (2) To identify generic and disease-specific determinants of effects.
(3) To obtain insight into patients* , partners* and professionals'
expectations of and experiences with the AET intervention.
Study design
A multicentre, single-blinded, randomized controlled clinical trial. A *post-
poned* information model randomisation will be used.
Intervention
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 and once a week in an
individually guided group session in a hospital (2) Usual care.
Study burden and risks
All patients will be asked to visit the university hospital / rehabilitation
centre 4 times over the study period of 10 months to participate in a physical
examination. The duration of these examinations will be less than 2 hours.
Additionally, patients receive questionnaires to fill out at home. The duration
for completing the questionnaires is approximately 1 hour. There are no costs
related to the interventions for the patients.
Possible medical risks related to the aerobe exercise therapy tests are
considered low. All participating centres are well experienced in providing
exercise therapy in patients with different neuromuscular diseases. Therefore,
the occurrence of medical events is considered minimal. Patients allocated to
the AET intervention group are supposed to participate in a 16 - week group and
home aerobe exercise program of 2 hours a week. According to results of a pilot
study, the aerobe exercise program is feasible and safe.
Considering the positive effects of AET known from preliminary pilot study it
can be concluded that the benefits outweigh the burden and minimal risk
associated with this study.
In order to obtain insight into patients*, partners* and professionals*
expectations of and experiences with the AET intervention, individual
interviews and focus groups will be organised, with a duration of a maximum of
2 and 3 hours, respectively. There are no risks associated with this responsive
research methodology.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26331.041.08 |