Study of Nerve Injuries and Physical Exercise

NCT06846788 | Not Yet Recruiting

• 1 other identifier: 2024-05306-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore if combining exercise with sensory training can help improve sensory function and reduce pain after an injury to the nerves in the arm and hand. The study will look at how exercise affects the BDNF protein (which helps nerves grow), how it impacts sensation, and how it might help manage pain. Research has shown that exercise is good for brain health, enhancing abilities such as focus, memory, and the ability to cope with stress. It also helps the brain release BDNF, which helps nerve cell growth and plasticity. Higher levels of BDNF might improve sensory function, but no previous study has investigated the combination of exercise and sensory training. Study aims to investigate:

• if it is possible to use a physical exercise program (using an exercise bike) for people with nerve injuries.
• how easy it is to recruit participants, how well they stick to the program
• if exercise can change BDNF levels and VO2max (a measure of fitness), and how these changes might relate to pain and sensory.
• if it's possible to run a bigger, more detailed study in the future and check if it could be helpful for patients. The researchers believe that combining exercise with sensory training could help reduce pain and improve sensation compared to traditional sensory training methods. Participants will:
• perform 30 minutes of exercise on a stationary bike, twice a week, for 6 weeks at a moderate level of effort. After the exercise, they will do 5-10 minutes of sensory training, with additional exercises to practice at home. The sensory training will follow a standard program designed to help retrain the brain to process sensory information.
• be subject to a blood sample Results will include sensory function, pain evaluation, patient reported outcome measures.

Conditions

Nerve Injury; Pain Management; Sensorial Disturbance

Keywords

physical exercise; sensory relearning; physical therapy; occupational therapy; hand surgery; nerve injury; pain management

Outcome Measures

Primary Outcomes (1)

• Feasibility recruitment rate

  Number of participants recruited per month.

  12 weeks

Secondary Outcomes (13)

• Change in interpretation of sensation in the hand measured with Static two-point discrimination (S2PD) using millimetres

  first session, 3 weeks, 6 weeks and 12 weeks

• Evaluate potential recovery or regeneration of nerve function Semmes-Weinstein Monofilament (SWM)

  first session, 3 weeks, 6 weeks and 12 weeks

• Retention and adherence to intervention

  At first session and continuously to 12 weeks

• Explore design and outcome measures

  12 weeks

• Explore trial design

  12 weeks

Study Arms (1)

Physical exercise

EXPERIMENTAL

The participants will perform supervised physical exercise on a stationary exercise bike, 30 minutes, 2 times a week, for 6 weeks. The exercise will be at moderate intensity (40-59 % VO2max).

Other: Physical exercise

Interventions

Physical exercise OTHER

A traditional sensory relearning rehab session will be performed after our intervention consisting of 30 minutes of physical exercise.

Also known as: Aerob exercise, sensory relearning

Physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peripheral nerve in the arm and hand, treated at the rehabilitation unit at Södersjukhuset, between 2010-2025
• days to 15 years after injury.
• Age above 18.

You may not qualify if:

• Psychiatric illness or substance addiction severe enough to make intervention impossible.
• Severe neurological disease.
• Severe diabetes mellitus with nerve complications.
• Severe cardiovascular disease where aerobic exercise is contraindicated.
• Unwillingness or medical inability to undergo the intervention.
• Insufficient knowledge of the Swedish or English language, which makes examination with patient-reported questionnaires impossible.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Handkirurgiska kliniken Södersjukhuset

Stockholm, Sweden, 118 83, Sweden

Location

MeSH Terms

Conditions

Agnosia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cecilia C Mellstrand Navarro, hand surgeon, ass professor

  Department of Clinical Science and Education, Karolinska Institutet, Department of Hand Surgery, Södersjukhuset Hospital, and Department of Clinical Sciences Danderyd Hospital, Karolinska Institutet, Section for Orthopaedics, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda V Evertsson

CONTACT

46812362072; linda.evertsson@ki.se

Cecilia C Mellstrand Navarro

CONTACT

46 709 28 01 14; cecilia.mellstrand-navarro@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass professor

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)