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

NCT ID: NCT05361018

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2024-10-30

Brief 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.

Detailed 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.

Conditions

Breast Neoplasm, Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Whole Body Vibration exercise - WBV

The vibration exercises take place on a tri-planar vibration platform (Power Plate) according to the initially determined setting for each individual (highest, though feasible neuromuscular response). . Each session lasts for about 15-30 min in total, leaving sufficient time for regeneration. Training consists of at least four vibration exercises, chosen from a standardized pool of exercises with increasing difficulty in order to allow for individual, optimal progression. All sessions and adherence are documented by the exercise supervisor. Adverse events are documented, and patients asked to give feedback regarding the feasibility and subjective impression of each individual setting. All training sessions will be supervised. The participants rating of perceived exertion (RPE) will be assessed immediately after each set of exercise.

Group Type: EXPERIMENTAL

Whole Body Vibration exercise - WBV

Intervention Type: OTHER

participants will be randomised to two different training interventions

Conventional Aerobic and Resistance exercise - CAR

exercise sessions commence with 20 min of moderate intensity continuous aerobic exercise at a rating of perceived exertion (RPE) of 13-15 on the Borg scale. Participants complete both resistance exercises and high intensity intermittent aerobic exercises during each session. The resistance training regimen consists of 8 exercises (leg press, biceps curls, triceps extensions, bench press, shoulder press, standing row, sit ups/Russian weighted abdominal twist, and prone lying back extensions. Participants complete 2 sets of 8-12 repetitions at an initial intensity of 70 % of their estimated 1 repetition maximum (1-RM) strength and increase to 80 % of estimated 1-RM when more than 12 repetitions can be correctly performed by the participant

Group Type: ACTIVE_COMPARATOR

Whole Body Vibration exercise - WBV

Intervention Type: OTHER

participants will be randomised to two different training interventions

Interventions

Whole Body Vibration exercise - WBV

participants will be randomised to two different training interventions

Intervention Type: OTHER

Other Intervention Names

Conventional Aeorbic and Resistance exercise - CAR

Eligibility Criteria

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 Criteria

• pre-existing neuropathy of other cause (eg, diabetes),
• given contraindications for WBV including instable bone metastases and severe cardiovascular disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Yvonne Wengstrom

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yvonne Wengström, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

Yvonne Wengstrom

Identifier Type: -

Identifier Source: org_study_id