Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Validity and reliability of outcome measures in polyneuropathy
  Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years.
• Другое Healthy controls
  Healthy controls will be tested, answer patient reported outcome measures, and wear accelerometer at baseline visit. There is no follow-up in the healthy control group.

Первичные конечные точки

• 10-meter Walk Test [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Six Spot Step Test [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• 6-minute Walk Test [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• 30 seconds Chair Stand Test [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Dynamic Gait Index [Срок оценки: At baseline, after 2-4 weeks, and after 1-2 years]
• Nine Hole Peg Test [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Jamar Hand-grip dynamometer (hand-grip-strength) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Isometric strength measured with hand-held dynamometer [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• SENS motion activity sensor (accelerometer) [Срок оценки: At baseline (study entry), and after 1-2 years]

Вторичные конечные точки (9)

• Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Falls Efficacy Scale-International (FES-I) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Composite Autonomic Symptom Score (COMPAS-31) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Fatigue Severity Scale (FSS) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• PittsburghSleep Quality Index [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Major Depression Inventory (MDI) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• International Physical Activity Questionaire (IPAQ) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
• Physical Activity Scale (PAS2) [Срок оценки: At baseline (study entry), after 2-4 weeks, and after 1-2 years]

Критерии участия

Критерии включения

Inclusion Criteria patients:

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

Inclusion Criteria healthy controls:

> 18 years Healthy

Критерии исключения

Exclusion Criteria patients:

Not verified polyneuropathy

Exclusion Criteria healthy controls:

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Дания · 1 центр

• Copenhagen Neuromuscular Center, Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT06040567 · H-23032160

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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