Clinical trial NCT06040567: Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Official title: Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Vasculitic Neuropathy
POEMS Syndrome
Multifocal Motor Neuropathy
Charcot-Marie-Tooth
hATTR Amyloidosis
Diabetic Polyneuropathy
Idiopathic Neuropathy
Polyneuropathies
Keywords: Polyneuropathy
Clinical outcome measures
Patient reported outcome measures (PROMs)
Physical activity
Accelerometer
Validity
Reliability
Responsiveness
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark

Brief summary: The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.

Detailed description: In four phases the investigators will evaluate physical activity and the validity, reliability, and responsiveness of the outcome measures in patients with polyneuropathy. During the four phases clinical outcome measures, patient-reported outcomes measures, and accelerometer data on physical activity will be evaluated. The investigators plan to include 400 adult patients with polyneuropathy (acquired, hereditary, and idiopathic) from our clinic and 120 adult healthy controls. The 400 patients with polyneuropathy include the following subtypes of polyneuropathy: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), vasculitis polyneuropathy, Polyneuropathy-Organomegaly-Endocrinopathy-Monoclonal protein-Skin changes (POEMS syndrome), Multifocal Motor Neuropathy (MMN), Charcot Marie Tooth (CMT), hATTR amyloidosis, Diabetic Polyneuropathy (DPN), and idiopathic neuropathy.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria patients:

\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)

Inclusion Criteria healthy controls:

\> 18 years Healthy

Exclusion Criteria:

Exclusion Criteria patients:

Not verified polyneuropathy

Exclusion Criteria healthy controls:

Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy

Primary outcomes:
measure: 10-meter Walk Test
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Six Spot Step Test
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: 6-minute Walk Test
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: 30 seconds Chair Stand Test
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Dynamic Gait Index
timeFrame: At baseline, after 2-4 weeks, and after 1-2 years
measure: Nine Hole Peg Test
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Jamar Hand-grip dynamometer (hand-grip-strength)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Isometric strength measured with hand-held dynamometer
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: SENS motion activity sensor (accelerometer)
timeFrame: At baseline (study entry), and after 1-2 years
measure: Inflammatory Neuropathy Cause and Treatment (INCAT)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Secondary outcomes:
measure: Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Composite Autonomic Symptom Score (COMPAS-31)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Fatigue Severity Scale (FSS)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: PittsburghSleep Quality Index
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Major Depression Inventory (MDI)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: International Physical Activity Questionaire (IPAQ)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
measure: Physical Activity Scale (PAS2)
timeFrame: At baseline (study entry), after 2-4 weeks, and after 1-2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, University of Copenhagen
name: Britt S Pedersen
role: STUDY_CHAIR
References: