The goal of this clinical trial is to learn about the cause of dizziness and decline in walking ability in in older adults ≥65 years during chemotherapy treatment for colorectal cancer. Another goal is to investigate if a comprehensive geriatric assessment and three months' specialized physical group-based exercise three times/week can counteract muscle weakness, vertigo, instability, impaired walking balance, and neuropathy
Frequent adverse effects of chemotherapy in older adults are nausea and fatigue, but our research group have discovered a problem with many also suffering from sarcopenia, vertigo, dizziness, and peripheral neuropathy (CIPN) leading to balance and walking impairments causing increased risk of falls. Moreover, these symptoms are often underreported with inadequate awareness among health professionals leading to deficient focus on the need for targeted rehabilitation. A comprehensive geriatric assessment (CGA) can increase the number of frail, older patients completing chemotherapy and CGA-based interventions can decrease chemotherapy toxicity and improve health-related quality of life (HRQoL). Physical exercise has been shown to reduce muscle weakness, vertigo, dizziness, and impaired balance among older adults requiring limited resources. Therefore, this project aims to investigate the effectiveness of CGA and physical exercise to counteract muscle weakness, vertigo, instability, and impaired walking balance, during chemotherapy and to investigate the interaction between vertigo, postural stability and walking performance, and neuropathy and the prevalence of sarcopenia. The activities of specialized physical exercise planned in this intervention will, as hypothesized, result in a change in muscle strength, walking balance, self-perceived balance disabilities/dizziness, and fear of falling along with changes in peripheral nerve function and autonomic function and severity of CIPN which are the outcomes of this study. Accordingly, expectations are that this intervention will affect the HRQoL among older cancer patients with vertigo and walking impairments and reduce the number of falls and hospital admissions leading to a socioeconomic benefit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark
NOT_YET_RECRUITINGCopenhagen University Hospital - Herlev and Gentofte Hospital
Herlev, Denmark
RECRUITINGDynamic Gait Index (DGI)
Between-group difference in change in walking balance assessed with Dynamic Gait Index (DGI) scored on a 0-24 point total scale. Higher score means better outcome
Time frame: Three months
30 second Sit-to-Stand Test (30STS)
Between-group difference in lower limb muscle strength and endurance
Time frame: Three months
Falls
Self-reported falls
Time frame: Baseline, two, four, six, eight, ten, twelve, fourteen, sixteen, eighteen, twenty, twenty-two, and twenty-four weeks
Hospital contacts due to falls
Hospital contacts due to falls
Time frame: Baseline, three and six months
Balance disabilities/dizziness
Changes in self-perceived balance disabilities/dizziness using the patient reported outcome measure Dizziness Handicap Inventory (DHI) scored on a 0-100 point total scale. Higher score means worse outcome
Time frame: Baseline, three and six months
Fear of falling
Changes in fear of falling using the patient reported outcome measure Short Falls Efficacy Scale International (Short FES-I) scored on a 0-28 point total scale. Higher score means worse outcome
Time frame: Baseline, three and six months
Health related quality of life
Changes in health related quality of life using the patient reported outcome measure EORTC QLQ-C30. The total score is converted to a 0-100 scale. Higher score means better outcome
Time frame: Baseline, three and six months
Peripheral nerve function
Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome
Time frame: Baseline, three and six months
Autonomic function
Changes in autonomic function using Vagus device
Time frame: Baseline, three and six months
Chemotherapy induced peripheral neuropathy
Severity of chemotherapy induced peripheral neuropathy using the patient reported outcome measure EORTC QLQ-CIPN-20. The total score is converted to a 0-100 scale. Higher score means worse outcome
Time frame: Baseline, three and six months
Muscle strength
Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms
Time frame: Baseline, three and six months
Body composition
Changes in body composition using DXA
Time frame: Baseline, three and six months
Muscle strength
Changes in muscle strength using handgrip test measuring weight in kilograms
Time frame: Baseline, three and six months
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