The SaVe project - Sarcopenia and Vertigo in aging patients with colorectal cancer: A study protocol for three randomized controlled trials.

INTRODUCTION: Older patients with cancer range from fit to frail with various comorbidities and resilience to chemotherapy. Besides nausea and fatigue, a significant number of patients experience dizziness and impaired walking balance after chemotherapy, which can have great impact on their functional ability and health related quality of life. Symptoms are easily overlooked and therefore often underreported and managed, which is why symptoms could end up as long-lasting side effects. The aim of this study is to investigate the development of dizziness, decline in walking balance, and sarcopenia and the effect of a comprehensive geriatric assessment and 12 weeks of group-based exercise on these symptoms. The exercise intervention includes vestibular and balance exercises, and progressive resistance training, to counteract the symptoms in older patients with colorectal cancer treated with chemotherapy. MATERIALS AND METHODS: This is a randomized controlled trial including patients ≥65 years initiating (neo)adjuvant or first-line palliative chemotherapy for colorectal cancer. Patients will undergo a comprehensive assessment program including measures of vestibular function, balance, muscle strength, mass, and endurance, peripheral and autonomic nerve function, and subjective measures of dizziness, concern of falling, and health related quality of life. Tests will be performed at baseline, 12, and 24 weeks. Patients will be placed in three different randomized controlled trials depending on chemotherapy regimen and randomized 1:1 to comprehensive geriatric assessment and exercise three times/week or control. Participants in both groups will continue with usual care, including standardized oncological treatment. In total, 150 patients are needed to assess the two primary outcomes of (1) maintenance of walking balance assessed with Dynamic Gait Index and (2) lower limb strength and endurance assessed with 30 Second Sit-to-Stand Test at 12 weeks. The primary outcomes will be analyzed using a mixed linear regression model investigating the between-group differences. DISCUSSION: Trial enrollment began in April 2023 and is the first trial to evaluate reasons for dizziness, decline in walking balance, and sarcopenia in older patients receiving chemotherapy. The trial will provide new and valuable knowledge in how to assess, manage, and prevent dizziness, decline in walking balance, and sarcopenia in older patients with colorectal cancer. TRIAL REGISTRATION: The Regional Ethics Committee (j.nr. H-22064206). Danish Data Protection Agency (P-2023-86) and ClinicalTrials.gov (NCT05710809).

Prevalence of bilateral vestibulopathy among older adults above 65 years on the indication of vestibular impairment and the association with Dynamic Gait Index and Dizziness Handicap Inventory.

PURPOSE: To estimate the prevalence of bilateral vestibulopathy (BV) and evaluate the association with, and concurrent validity of the Dynamic Gait Index (DGI) and the Dizziness Handicap Inventory (DHI) in diagnosing BV based on video head impulse test (vHIT) among older adults ≥65 years referred to a geriatric falls clinic on suspicion of vestibular impairment. MATERIALS AND METHODS: The vHIT was applied as a reference standard of BV to estimate diagnostic parameters for optimal cut-off scores of DGI and DHI applied separately and in combination. RESULTS: Two-hundred medical records were reviewed (70% women, mean age 79.4 years). The prevalence of BV was 9%. DGI was weakly associated with BV: Odds Ratio (OR) 1.15 (95% confidence interval (CI): 1.01; 1.31), with a 93% sensitivity and 47% specificity of a cut-off score of 16. The total score of DHI showed no association with BV: OR 1.01 (95% CI: 0.98; 1.04). The concurrent validity for BV and DGI and/or DHI were found to be inadequate. CONCLUSIONS: A prevalence of 9% underlines the relevance for assessment of BV. Only a weak association between DGI and/or DHI and BV was found. Thus, vHIT remains the preferred test for detecting BV in geriatric fall assessments.IMPLICATIONS FOR REHABILITATIONBilateral vestibulopathy (BV) has numerous negative consequences for older adults and the prevalence is high among older adults referred to a geriatric falls clinic on suspicion of vestibular impairment.The Dynamic Gait Index (DGI) and the Dizziness Handicap Inventory (DHI) are not valid alternatives to the Video Head Impulse Test (vHIT) when assessing BV among geriatric outpatients.

Prevalence of sarcopenia in a Danish geriatric out-patient population.

INTRODUCTION: The prevalence of sarcopenia varies extensively depending on the definitions and studied populations. The aim of this study was to assess the prevalence of sarcopenia in a Danish geriatric out-patient population using criteria from the European Working Group on Sarcopenia (EWGSOP). METHODS: Patients referred to a geriatric out-patientclinic were included. Using the EWGSOP´s recommendations, appendicular skeletal muscle mass (ASM), hand-grip strength (HGS) and gait speed (ten-meter walk (GS)) were assessed. Skeletal muscle mass index (SMI) was calculated by ASM/height2 (kg/m2), and patients were classified with: no sarcopenia (normal SMI), pre-sarcopenia (reduced SMI, normal HGS and GS), sarcopenia (reduced SMI and reduced HGS or GS) or severe sarcopenia (reduced SMI, HGS and GS). RESULTS: A total of 189 patients were screened, 80 were included. In all, 12 (15%) had severe sarcopenia, nine (11%) sarcopenia, eight (10%) pre-sarcopenia and 51 (64%) no sarcopenia. Mean age was significantly higher in the SARC- group (sarcopenia and severe sarcopenia) than in the NOSARC-group (pre-sarcopenia and no sarcopenia) (p = 0.009), and BMI was significantly lower in the SARC-group (p < 0.0001). No difference was found in gender distribution (p = 0.729). CONCLUSIONS: 26% of patients in a geriatric out-patient population had sarcopenia, which highlights that this is a common condition. Standard assessments can identify functional limitations, but not sarcopenia. The EWGSOP's recommendations are feasible, and we suggest that they should form part of the standard clinical comprehensive geriatric assessment. FUNDING: none. TRIAL REGISTRATION: not relevant.