Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study (PolyImPAct)

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.

Study Overview

• Status: Recruiting
• Conditions: Polyneuropathies; Diabetic Polyneuropathy; Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); POEMS Syndrome; Multifocal Motor Neuropathy; Charcot-Marie-Tooth; hATTR Amyloidosis; Vasculitic Neuropathy; Idiopathic Neuropathy
• Intervention / Treatment: Other: Validity and reliability of outcome measures in polyneuropathy; Other: Healthy controls

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.

• Study Type: Observational
• Enrollment (Estimated): 520

Contacts and Locations

• Study Contact: Name: Britt S Pedersen; Phone Number: +4535458401; Email: britt.staevnsbo.pedersen.01@regionh.dk
• Study Contact Backup: Name: Tina Dysgaard; Email: tina.dysgaard@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Copenhagen Neuromuscular Center, Rigshospitalet
    • Contact: Britt S Pedersen; Phone Number: +4535458401; Email: britt.staevnsbo.pedersen.01@regionh.dk
    • Contact: Tina Dysgaard; Phone Number: +4535458077

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from a the neuromuscular clinic at Rigshopitalet, Copenjagen, Denmark

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with polyneuropathy; Adults (> 18 years) diagnosed with polyneuropathy	Other: 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.
Healthy controls; Healthy adults (>18 years)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-meter Walk Test	The patient is asked to 10 meter as fast as possible	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Six Spot Step Test	The patient is instructed to walk 5 meters as fast as possible, while kicking five cylinder blocks out of five circles marked on the floor.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
6-minute Walk Test	The patient will be asked to walk back and forth along a 25 meter walkway for six minutes. They will be instructed to walk as far as possible for six minutes.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
30 seconds Chair Stand Test	The patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Dynamic Gait Index	The patient will be asked to walk while performing different tasks (walking: normally, while changing speed, while turning head (vertical and horizontal), while turning around, while stepping over obstacles, and walking stairs).	At baseline, after 2-4 weeks, and after 1-2 years
Nine Hole Peg Test	Fine motor skills	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Jamar Hand-grip dynamometer (hand-grip-strength)	Best of three values	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Isometric strength measured with hand-held dynamometer	Will be tested bilateral at ankle, knee, wrist and elbow	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	Will be tested bilateral at ankle and knee	At baseline (study entry), after 2-4 weeks, and after 1-2 years
SENS motion activity sensor (accelerometer)	The SENS motion activity sensor is a wearable accelerometer. It measures physical activity by collecting raw data of accelerations. Data on active time, sedentary time, time spent walking and number of steps taken will be collected. The sensor will be attached and worn 24/7 (the sensor will be worn the week following baseline tests, and the week after tests at visit three (1-2 years after baseline).	At baseline (study entry), and after 1-2 years
Inflammatory Neuropathy Cause and Treatment (INCAT)	Interview based disability scale INCAT evaluates disability of the upper and lower limb. The total INCAT score ranges from 0-10 (low scores indicating no disability and higher scores indicating higher level of disability).	At baseline (study entry), after 2-4 weeks, and after 1-2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS)	I-RODS is a 24-item patient reported outcome measure that measures disability. The raw score ranges from 0-48, with 0 indicating severe disability and higher scores indicating lower levels of disability.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Falls Efficacy Scale-International (FES-I)	Assesses limitations related to fear of falling. FES-I is a 16-item patient reported outcome measure that measures fear of falling. The score ranges from 16-64, with higher scores indicating greater fear of falling.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Composite Autonomic Symptom Score (COMPAS-31)	Assesses autonomic dysfunction Compass-31 is a patient reported outcome measure that measures autonomic dysfunction. Scores ranges from 0-100, with higher scores indicating more severe symptoms of autonomic dysfunction.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS)	Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Fatigue Severity Scale (FSS)	Assesses fatigue FSS is a 9-item patient reported outcome measure that measures fatigue, and the impact of fatigue on physical activity and daily living. The score ranges from 9-63, with a higher score indicating higher levels of fatigue.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
PittsburghSleep Quality Index	PittsburghSleep Quality Index is a patient reported outcome measure that assesses sleep quality. The score ranges from 0-21, with higher scores indicating more affected sleep quality	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Major Depression Inventory (MDI)	MDI is a patient reported outcome measure that measures depressive symptoms. The score ranges from 0-50, with higher scores indicating deeper depression.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
International Physical Activity Questionaire (IPAQ)	International Physical Activity Questionaire (IPAQ) is a patient reported outcome measure that measures physical activity.	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Physical Activity Scale (PAS2)	PAS2 is a 7-item patient reported outcome measure that measures physical activity and sedentary behavior.	At baseline (study entry), after 2-4 weeks, and after 1-2 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Chair: Britt S Pedersen, Rigshospitalet, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Validity; Reliability; Accelerometer; Polyneuropathy; Responsiveness; Clinical outcome measures; Patient reported outcome measures (PROMs)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Mellitus; Diabetes Complications; Hematologic Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Immunoproliferative Disorders; Congenital Abnormalities; Abnormalities, Multiple; Heredodegenerative Disorders, Nervous System; Paraproteinemias; Blood Protein Disorders; Proteostasis Deficiencies; Nervous System Malformations; Polyradiculoneuropathy; Polyneuropathies; Peripheral Nervous System Diseases; Diabetic Neuropathies; Amyloidosis; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; POEMS Syndrome
• Other Study ID Numbers: H-23032160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No