Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy

Last updated: November 14, 2024
Sponsor: Karolinska Institutet
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

Whole Body Vibration exercise - WBV

Clinical Study ID

NCT05361018
Yvonne Wengstrom
  • Ages 18-80
  • Female

Study Summary

CIPN is induced by neurotoxic chemotherapeutic agents and manifests with sensory and/or motor deficits. It is associated with significant disability and poor recovery. Common symptoms include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. The purpose of the study is to compare effects of sensory vibrations training to conventional aerobic and strenght exercise on neurophatic symptoms related to chemotherapy treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with breast cancer, aged 18-80 years,

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2,

  • completed chemotherapy in the past 3 months. Experiencing symptoms of CIPN

Exclusion

Exclusion Criteria:

  • pre-existing neuropathy of other cause (eg, diabetes),

  • given contraindications for WBV including instable bone metastases and severecardiovascular disease.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Whole Body Vibration exercise - WBV
Phase:
Study Start date:
October 17, 2022
Estimated Completion Date:
October 30, 2024

Study Description

Aim: To (a) compare the effects of WBV exercise compared to regular cardiovascular and resistance exercise (CAR) on the primary outcome of (a) CIPN symptoms and secondary outcomes of (b) balance, physical function, and quality of life.

Based on previous pilot study findings, we hypothesize that WBV exercise compared to CAR will reduce relevant symptoms to a larger degree, such as the loss of peripheral deep sensitivity, pain, weakened or absent reflexes and loss of balance control (aim a) and that patients will experience an improvement in physical function and quality of life (aim b).

The study employs a prospective, multicenter, two-armed, randomized controlled design. Study participants will be informed about the study procedure and sign a written informed consent. Patients will then be assigned randomly either to the WBV group or the CAR group. Patients allocated to the WBV group receive a defined WBV exercise program twice a week in addition to their usual treatment. Patients in conventional aerobic and resistance exercise (CAR) group will receive a defined exercise program twice a week in addition to their usual treatment.

Connect with a study center

  • Karolinska University Hospital

    Stockholm, 11447
    Sweden

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.