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

• ClinicalTrials.gov Identifier: NCT06040567
• Recruitment Status: Recruiting
• First Posted: September 15, 2023
• Last Update Posted: November 18, 2023
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Britt Stævnsbo Pedersen, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Vasculitic Neuropathy; POEMS Syndrome; Multifocal Motor Neuropathy; Charcot-Marie-Tooth; hATTR Amyloidosis; Diabetic Polyneuropathy; Idiopathic Neuropathy; Polyneuropathies	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 Design

• Study Type: Observational
• Estimated Enrollment: 520 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
• Actual Study Start Date: September 23, 2023
• Estimated Primary Completion Date: December 31, 2026
• Estimated Study Completion Date: December 31, 2026

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 10-meter Walk Test [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   The patient is asked to 10 meter as fast as possible
2. Six Spot Step Test [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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.
3. 6-minute Walk Test [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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.
4. 30 seconds Chair Stand Test [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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
5. Dynamic Gait Index [ Time Frame: At baseline, after 2-4 weeks, and after 1-2 years ]
   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).
6. Nine Hole Peg Test [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   Fine motor skills
7. Jamar Hand-grip dynamometer (hand-grip-strength) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   Best of three values
8. Isometric strength measured with hand-held dynamometer [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   Will be tested bilateral at ankle, knee, wrist and elbow
9. Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   Will be tested bilateral at ankle and knee
10. SENS motion activity sensor (accelerometer) [ Time Frame: At baseline (study entry), and after 1-2 years ]

    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).

11. Inflammatory Neuropathy Cause and Treatment (INCAT) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
    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).

Secondary Outcome Measures :

1. Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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.
2. Falls Efficacy Scale-International (FES-I) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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.
3. Composite Autonomic Symptom Score (COMPAS-31) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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.
4. Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   Assesses neuropathic pain S-LANSS is a patient reported outcome measure for identifying neuropathic pain.
5. Fatigue Severity Scale (FSS) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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.
6. PittsburghSleep Quality Index [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   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
7. Major Depression Inventory (MDI) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   MDI is a patient reported outcome measure that measures depressive symptoms. The score ranges from 0-50, with higher scores indicating deeper depression.
8. International Physical Activity Questionaire (IPAQ) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   International Physical Activity Questionaire (IPAQ) is a patient reported outcome measure that measures physical activity.
9. Physical Activity Scale (PAS2) [ Time Frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years ]
   PAS2 is a 7-item patient reported outcome measure that measures physical activity and sedentary behavior.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Contacts

Contact: Britt S Pedersen; +4535458401; britt.staevnsbo.pedersen.01@regionh.dk

Contact: Tina Dysgaard; tina.dysgaard@regionh.dk

Locations

Denmark

Copenhagen Neuromuscular Center, Rigshospitalet; Recruiting

Copenhagen, Denmark, 2100

Contact: Britt S Pedersen +4535458401 britt.staevnsbo.pedersen.01@regionh.dk

Contact: Tina Dysgaard +4535458077

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

• Study Chair: Britt S Pedersen; Rigshospitalet, University of Copenhagen

More Information

• Responsible Party: Britt Stævnsbo Pedersen, Principal Investigator, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT06040567
• Other Study ID Numbers: H-23032160
• First Posted: September 15, 2023
• Last Update Posted: November 18, 2023
• Last Verified: November 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Britt Stævnsbo Pedersen, Rigshospitalet, Denmark:

Polyneuropathy; Clinical outcome measures; Patient reported outcome measures (PROMs); Physical activity; Accelerometer; Validity; Reliability; Responsiveness

Additional relevant MeSH terms:

Polyneuropathies; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Diabetic Neuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; POEMS Syndrome; Amyloidosis; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Paraproteinemias