1. study the effects of an 8-week high-intensity interval training on motor and non-motor aspects (primary outcome: anxiety and depression) of Parkinson's disease and Multiple Sclerosis, compared to traditional continuous aerobic training and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anxiety and depression (HADS)
Secondary outcome
Disease severity (UPDRS, EDSS)
Cognition (Stroop, TMT, SDMT)
Fatigue (CIS-20r)
Sleep quality (ISI)
Well-being/disease impact (PDQ-8, MSIS)
Quality of life (SF-36)
Fysieke prestatie (10MWT, TUG, NHPT)
ADL (NEADI)
Fysieke activiteit (PASIPD)
Hersennetwerk connectiviteit (MRI)
Background summary
People with Parkinson's disease and Multiple Sclerosis experience, in addition
to motor symptoms such as difficulty with walking, balance, and coordination,
non-motor complaints such as anxiety and depression, impaired cognition,
fatigue, and sleeping problems, which has a major impact on everyday
functioning. Pharmacological treatments work insufficiently (and/or
side-effects occur) to adequately improve these problems. Alternative
rehabilitation strategies may therefore be of great value for these patients
considering the sub-optimal effect of current treatment options in reducing
disease complaints. Preferably, these interventions also have a
disease-modifying effect on both motor and non-motor symptoms and promote
neuroplasticity.
Being physically active contributes to someone's health and physical training
is therefore an important part of Rehabilitation Medicine in terms of reducing
symptoms. Additionally, physical training seems promising for promoting neural
plasticity. In people with Parkinson's disease and Multiple Sclerosis,
biomarkers of neuroplasticity (e.g., brain-derived neurotrophic factor (BDNF))
and neurodegeneration (e.g., neurofilament light (NfL)) are present at reduced
and increased levels, respectively. Previous research demonstrated that BDNF
responds well to physical training as an increase in BDNF protein level is
associated with improvement of motor and non-motor symptoms; the effect on NfL
is currently unknown.
The most effective type of physical training for improving motor and non-motor
symptoms as well as promoting neuroplasticity is unknown. High-intensity
interval training seems promising, and superior to traditional continuous
aerobic training, to stimulate such physical, mental, and neurtrophic effects,
all within considerable shorter training duration. Although promising, the
effects of this training strategy have not yet been well studied in people with
Parkinson's disease and Multiple Sclerosis.
Study objective
1. study the effects of an 8-week high-intensity interval training on motor and
non-motor aspects (primary outcome: anxiety and depression) of Parkinson's
disease and Multiple Sclerosis, compared to traditional continuous aerobic
training and movement advice; and 2. study the association between
neuroplasticity and neurodegeneration blood-based biomarkers, brain network
function, and motor and non-motor symptoms, both within and between
intervention groups.
Study design
This project has an ABA design, including A baseline, B intervention
(high-intensity interval training, continuous aerobic training, or movement
advice) with frequent repeated measurements. Participants are randomly
allocated to 1 of 3 intervention groups. The study begins with a baseline
period (no training or movement advice) for 4 weeks, followed by an 8-week
intervention period (high-intensity interval training, continuous aerobic
training, or movement advice), and lastly, a follow-up of 4 weeks.
Visual inspection and regression analysis are used to analyse individual trends
in outcome measures within and between intervention arms. In addition, Pearson
correlation coefficients are calculated to explore the association between
motor and non-motor symptoms, neuroplasticity and neurodegeneration biomarkers
in blood, and brain network connectivity.
Intervention
The intervention period lasts 8 weeks, consisting of 1. high-intensity interval
training: 2x/week, workload alternates (45 sec at >85% of Wmax; 90 sec at
20-30% of Wmax) during a 30-minute session (cycle ergometer); 2. continuous
aerobic training: preset workload of 55% of Wmax during 50-minute session
(cycle ergometer); 3. movement advice: program with pedometer and weekly step
goals, and information about the added value of being physically active (from
home).
Study burden and risks
All participants may benefit from this study because being physically active
positively contributes to someone*s health; however, the extent can vary
between intervention groups. Participants that are assigned to high-intensity
interval training and continuous aerobic training perform training sessions
twice a week for 8 weeks under the supervision of an experienced
physiotherapist this can be at the Amsterdam UMC, location VUmc or at a
participants own physiotherapist. Assessment of outcome measures will be
scheduled on training/measurement days as much as possible. Participants that
are assigned to the movement advice group visit Amsterdam UMC, location VUmc
pre- and post-baseline, intervention, and follow-up for the assessment of
outcome measures. During baseline and follow-up, participants are asked at
multiple time points to fill out short questionnaires at home and visit
Amst4erdam UMC, location VUmc for measurements.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
1. diagnosis of Parkinson's disease (PD) or Multiple Sclerosis (MS); 2. Hoehn &
Yahr stage <4 (PD), EDSS score <6 (MS); 3. symptoms of disturbed affect,
including anxiety and depression [HADS score >=8 on anxiety and/or depression
subscale]; 4. able to participate in physical exercise program (i.e., no
history of heart programs, no symptms that might indicate heart problems (e.g.,
disturbed resting ECG), no other major health issues); 5. sufficient cognitive
ability to comprehend training instructions [MoCA score >21]; 6. stable
medication regime for at least four weeks; and 7. age >=18 years
Exclusion criteria
1. participation in physical exercise program <1 month prior; 2. for people
with Multiple Sclerosis, relapse <1 month prior; 3. psychiatric,
musculoskeletal, or metabolic disorders prohibiting participation in physical
exercise program; 4. complaints of cardiovascular, pulmonary, and/or metabolic
abnormalities or cardiovascular, pulmonary, and/or metabolic abnormalities tgat
are not well controlled with medication, following the Lausanne protocol
(questionnaire, physical examination, cardiogram), in accordance with the
protocol on Kwaliteitsnet 'Bewegingslab ISL: beslisboom inspanningstest
spiro-ergometrie-REV, versie 1' at the department of Rehabilitation Medicine of
Amsterdam UMC location VUmc; 5. abnormal resting ECG; and 6. suicidal ideation
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 | NL78096.029.21 |