STABLE (Strength and Balance Leg Exercise) Study

Summary

Participation Requirements

Description

METHODOLOGICAL APPROACH Hypothesis: a 3-month strength and balance training program, delivered to the sample group virtually, will result in improvement of balance, increase in lower body strength, as well as lower fall rates compared to control. The proposed STABLE (Strength Training And Balance Le...

METHODOLOGICAL APPROACH Hypothesis: a 3-month strength and balance training program, delivered to the sample group virtually, will result in improvement of balance, increase in lower body strength, as well as lower fall rates compared to control. The proposed STABLE (Strength Training And Balance Leg Exercise) study is an observer-blinded, parallel group (IG vs. CG) randomized controlled feasibility trial. If found effective, findings from this study can inform a subsequent, larger scale trial to inform design of definitive phase III trial. 1.1 Research questions: What are the preliminary effects of a 3-month, online, supervised strength and balance exercise program on lower body strength, balance, and fall rates in community-dwelling older adults with cancer? What is the feasibility of this 3-month online, supervised, exercise program in terms of recruitment, retention, outcome capture, completion, and acceptability? 1.2 Study participants will be recruited over a two-year period from the cohort of older adults across Saskatchewan, using a CHASR survey. The research assistant will inquire about the availability of patients who may fit the eligibility criteria for this study. Eligible patients will be called (pending permission) by the research assistant and provided with a description of the study and an opportunity to ask questions. Posters to advertise the study will also be placed in waiting areas of oncology clinics and chemo infusion clinics. The informed consent process will also include obtaining participants' permission to collect information from their medical chart, including comorbidities, cancer type, stage, treatment intent and type, and drug name. Inclusion criteria for this study are as follows: older adults aged 65 or above; living in the community; have a confirmed diagnosis of any stage of lung, breast, prostate, or colorectal cancer (the most common cancer sites in older adults); receiving or starting systemic chemotherapy or hormone therapy; life-expectancy of at least 9 months (in consideration of the measurement period of the study and also avoid burdening patients who are near the end-stage of their disease); and have their treating physician's approval to participate. Exclusion criteria are as follows: presence of brain metastases; presence of unstable metastases as per treating physician (e.g., bone metastasis in a weight-bearing area, recent bone fracture); presence of any conditions that would potentially interfere with their ability to carry out the exercise interventions (e.g., mobility impairment, poorly controlled pain, severe vision/hearing loss, severe arthritis that limits ambulation, left-sided heart failure, neurological or musculoskeletal conditions); recent history of light-headedness during physical activities; syncopal episodes within the past month; and participation in any form of structured exercise program (minimum 30 mins per week) at the time of consent. 1.3 Outcomes will be measured at, and at 3 months (t1: intervention period is complete). All outcome assessments will be carried out by a trained registered nurse who is blinded to group allocation and not involved in analysis of study results. Participants will complete the baseline assessment, including a survey (sociodemographic information, functional status, fall history, fall efficacy) and an assessment of lower body strength and balance. For IG participants, a separately scheduled 3-month data collection will also include an exit survey to collect participants' opinions regarding the intervention, any difficulties related to exercising and adherence, as well as feedback for future improvement. 1.4 Randomization Procedure/ Sample Size: The randomization will be generated by Research Electronic Data Capture software. Participants will be randomized into parallel groups with a 1:1 allocation ratio to either intervention group (IG) or control group (CG). A recruitment goal of 30 IG participants and 30 CG (total 60 participants) will provide precise estimates of parameters related to the primary outcomes and important feasibility information that will be vital to inform our subsequent, larger trial. To address the potential limitation of attrition and loss-to-follow-up, we will recruit at least 73 participants to anticipate a 14% - 18.7% loss to follow-up based on recent research in older adults with cancer (78,79). Research suggests 80% as a minimum acceptable follow up (80). 1.5 Intervention: The STABLE program is informed by the prescription of the Otago program (31), known for targeting strength and balance to prevent falls in older adults, and designed for a frequency of three times per week (81,82). Specifically, it consists of leg muscle strengthening and balance training exercises that progress in difficulty. This program has been shown to be effective in reducing the number of falls and fall-related injuries by 35% in community-dwelling older adults. IG participants will receive orientation and learn the exercise routines through a digital platform. A Certified Exercise Physiologist (CEP) will meet with each participant to provide instructions regarding the exercise and provide an overview of exercise safety precautions. The training load will be tailored and adjusted for each participant to ensure optimal benefit from the exercise, it will also include orienting the participant to the iPad and how to connect to the virtual training sessions. An Apple iPad/internet access service will be provided to the IG participants who require them. Participants will be supervised through the strength and balance training for 3 months (20-30 minutes per scheduled session, three times a week) from home by the CEP. The PI/CEP will phone each participant in the home exercise group every week to check in, remind them about attending exercise sessions, provide support, and answer questions. Exercise trials in older adults with cancer have been found to be safe and adverse events are rare, therefore, this study anticipates a low adverse event rate for this study. Any adverse events during the training sessions will be documented and graded using the Common Terminology Criteria for Adverse Events version 4 (90). 1.6 Control: The CG will allow inferences that can be made on the preliminary effect of the prescribed exercises. Participants in the CG will not receive the intervention and will be advised to carry out their usual daily activities. 1.7 Progression of balance training will occur by graduating from holding onto a stable structure to performing the exercise independent of support (81). For the strength-training component, based on the recommendations by the ACSM, the training load will be increased by 2-10% once the participant can comfortably perform 15 repetitions for all sets on two consecutive training sessions. 1.8 Participants who report falls will be asked about circumstances of their falls (as per the recommendations of the American Geriatrics Society/British Geriatrics Society (AGS/BGS) (91)), and will be referred for appropriate follow-up (e.g. CEP, family physician, treating oncologist, and/or geriatric team). 1.9 Measures: Falls: Falls will be assessed at study completion self-report following recommendations of fall assessment as outlined by the American Geriatrics Society/British Geriatrics Society (AGS/BGS) (91). Lower body strength: Lower body strength will be assessed using the 5-times Chair Stand test (92 which is shown to be highly reliable and is a commonly used tool for measuring lower limb strength in older adults (94). Balance: Static balance ability will be measured using the Side-by-side Stand (SBS), Semi-tandem Stand, and Full tandem Stand (92). Feasibility: Recruitment rate, retention rate and adherence will all be calculated during the study (96). Acceptability will be assessed using an open-ended exit survey to collect information on participants' perceptions regarding: (1) the intervention; (2) any difficulties related to the exercise training and adherence; (3) level of satisfaction; and (4) suggestions for change/improvement for future participants. Development of the survey questions are informed by previous research on exercise program in older adults (97) as well as the expert consensus of the research team. Functional status will be assessed using the 7-item, validated Older Americans' Resources and Services (OARS) instrumental activities of daily living (IADL) scale (98). This instrument covers tasks necessary for independent living in the community (98). Fall Efficacy - Fall Efficacy Scale-International: The Fall Efficacy Scale-International (FES-I) (99) will be used to assess for fear-of-falling. 2.0 Data related to exercises and falls will be recorded on excel spreadsheets by the CEP and by the research nurse respectively. Group allocation for participants will be stored in a password-protected, secure file database. Paper surveys will be stored in the PI's office in a locked cabinet. All data collected from participants will be de-identified and entered into a separate, password-protected, secure database (Research Electronic Data Capture [RedCap7.1.1]). 2.1 Data Analysis: Statistical analysis: Data will be entered into IBM SPSS Version 27.0 for analysis and assessed for normality before inferential statistics will be conducted. To avoid bias in estimating the intervention effect, an intention-to-treat analysis will be. Descriptive will be used to describe patient characteristics (i.e. age, sex, gender, number of comorbidities and medications, cancer site, stage, treatment type) as well as use of mobility aid, functional status, and fall efficacy. Descriptive statistics (medians, numbers, and proportions) will be used to report muscle strength scorings, balance scores, and fall rates at T0 and T1. T-test will be performed to compare differences between the two groups at T0 and T1. Main effects and interaction effects paired with appropriate effect sizes (e.g., Eta square) will be calculated. Descriptive Stats will also be used to analyze recruitment rate, retention, adherence, outcome capture, and completion (based on the entire sample and also based on genders). Data from exit surveys will be summarized to determine general ways in which study procedures and participation experience could be improved for participants in future studies. Ethical consideration: Prior to the start of the study, ethics approval will be sought from the University Saskatchewan, and operational approval will be sought from the Saskatchewan Cancer Agency and the Saskatchewan Health Authority. Participants will be informed that they can withdraw from the study at any time, data collected up to their withdrawal will be included; however, no further data will be collected. Potential Pitfalls and Limitations: As with any research studies, participant accrual could potentially be an issue. However, prior research by members of the research team (SS and SA) found that older adults are very willing to participant in research studies, especially if they know that findings of study may potentially help others in the future (103). Another potential pitfall is attrition which is inevitable in most cohort studies and can occur for several reasons (death, disease progression, decline of health, or no longer interested to participate). This may lead to bias and weakens statistical power. To anticipate this potential limitation, we will recruit at least 73 participants. KNOWLEDGE TRANSLATION PLAN The target audience for this research is researchers in the field of geriatric oncology (especially those with an interest in functional and health outcomes in older adults with cancer), as well as clinicians and knowledge users in the field. The study will be reported following the Consolidated Standards of Reporting Trials (CONSORT) checklist (109).

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