Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Diabetic Polyneuropathy Clinical Trial

— PolyImPAct  

Official title:

Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040567
• Other study ID #: H-23032160
• Status: Recruiting
• Start date: September 23, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Britt S Pedersen
• Phone: +4535458401
• Email: britt.staevnsbo.pedersen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Charcot-Marie-Tooth
• Charcot-Marie-Tooth Disease
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• hATTR Amyloidosis
• Hereditary Sensory and Motor Neuropathy
• Multifocal Motor Neuropathy
• Nerve Compression Syndromes
• POEMS Syndrome
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Vasculitic Neuropathy

Intervention

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 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.

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Nine Hole Peg Test	Fine motor skills	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Primary	Jamar Hand-grip dynamometer (hand-grip-strength)	Best of three values	At baseline (study entry), after 2-4 weeks, and after 1-2 years
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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