Balance, Agility, Strengthening Exercise (BASE) class intervention - a 6-week exercise class to determine the change in balance performance, fear of falling and self-efficacy

The BASE class will be conducted twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

Balance, Agility, Strengthening Exercise (BASE) Class

Karen Dobbin, MSc

Cancer treatments can have a significant impact on a cancer survivor's function and independence, and these patients can have twice the incidence of falls than their cancer-free peers. Balance programs of varying lengths have shown to improve balance performance, increase self-efficacy and decrease fear of falling; however, there are limited intervention studies amongst cancer survivors, and none that examine the combination of balance performance, self-efficacy and fear of falling. It is believed that this study will show that a 6-week Balance, Agility, Strengthening Exercise (BASE) Class is a sufficient time frame to demonstrate a positive effect on balance performance, self-efficacy, and fear of failing in cancer survivors, and will add to the body of knowledge in this population.

Objectives Given that this combination of outcomes have not been sufficiently measured in the cancer population, and most balance and agility training programs are 12 weeks or more in length, the objectives of this study is to determine the effects of a 6-week intervention, the Balance, Agility, Strengthening Exercise (BASE) Class, on the balance performance, self-efficacy, and the fear of falling in cancer survivors.

Methods This study is a 3 year exercise interventional study, with 20 participants per year. In year one of the study, 20 participants will be enrolled in a 6-week Balance, Agility, Strengthening Exercise (BASE) Class. The pre-program data collection will include: demographic data; initial intake examination utilizing standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life. The participants will attend the BASE class twice weekly for 6-weeks. The post-program data collection is to include the same outcome measures.

Subsequent years will be an observational study of the same design, enrolling 20 participants in year 2 and 3 for a 6-week BASE class. A total of 60 participants will be recruited over 3 years providing adequate power to assess program efficacy. Based on the resources available, this study can only accommodate 20 participants per year and can only be conducted for a 6-week period each year of the study.

Participants and recruitment Posters and hand bills will be distributed and placed throughout CancerCare recruiting participants for the study (self-referral). In addition, hand bills will provided for oncologists, oncology nurses, and psychosocial clinicians to give to patients/potential participants within the clinical areas at CancerCare. After receiving the hand bill with the study description and information, potential participants can choose to phone or e-mail the PI to indicate their interest in the study. A phone interaction will take place between the PI and potential participant to determine if they meet the inclusion criteria. Once it is determined that they meet the inclusion criteria, an in-person meeting will be arranged and they will be provided with the study's objectives, risks and benefits, and the consent document. Time will be allowed for the potential participant to ask questions and to consider their enrollment in the study. After a thorough discussion and review of the documents, the potential participant will be asked to sign the consent form. If requested, a person will be allowed to take the consent form home for further consideration prior to signing.

Data collection Prior to the start of the BASE Class, an initial assessment will take place. This assessment will utilize standard physiotherapy assessment of range of motion, flexibility, and strength; use of validated balance performance tools; and validated self-report surveys for balance confidence, fear of falling, and quality of life.

Intervention:

The BASE class will run twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.

Statistical Analysis Pre-post paired comparisons will be conducted for each balance performance and self-reported questionnaire measure. A paired T-test or Wilcoxon signed ranks test will be performed according to the observed distributions.

The Effects of a 6-week Balance, Agility, Strengthening Exercise Class

The Effects of a 6-week Balance, Agility, Strengthening Exercise (BASE) Class on Balance Performance, Self-Efficacy, and Fear of Falling in Cancer Survivors

Mini-Balance Evaluation Systems Test is a 14-item balance scale covering a broad spectrum of performance tasks including dynamic body stability, transfers, gait, variation of support surfaces, and of visual conditions, obstacle negotiation, reactions to external forces and performance during dual-tasking.

Timed Up and Go: a rise from a chair, 3-meter walk, turn and walk back to chair and sitting. Designed to measure mobility, balance, and locomotor performance; evaluates falls risk and basic functional mobility.

A simple test for measuring static aspects of balance ability, measured in seconds with eyes open and eyes closed; useful when combined with other balance performance tests.

A 6-meter walking test measured in meters/second; an indicator of walking ability, function, and mobility.

A timed measurement of stepping whilst changing direction to provide a measure of dynamic standing balance and mobility; stepping forwards, sideways, and backwards over obstacles in a specified sequence.

Activities-specific Balance Confidence Scale is a 16-item self-report questionnaire examining a person's confidence in a broad range of activities with various difficulties; to assess balance confidence in ambulatory community-dwelling older adults

Modified Fall Efficacy Scale International is a 15 question self-rated scale assessing a person's confidence in performing activities in the home, plus additional items related to outdoor activities.

A 14 item scale that examines fear of falling and the effect it has on participation in various activities

Functional Assessment of Cancer Therapy - General is a 27-item self-report instrument that consists of 4 sub-scales: physical well-being, social well-being, emotional well-being, and functional well-being to measure quality of life for cancer patients.

University of Manitoba

Principal Investigator, Clinical Instructor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Musculoskeletal Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Kidney Diseases

Hypertension

Diabetes Mellitus

Stroke

Arthritis

Lung Diseases

Frailty

Heart Failure

Chronic Disease

Osteoporosis

Bone Diseases

Bone Diseases, Metabolic

Heart Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Metabolic Diseases

Respiratory Tract Diseases

Disease Attributes

Chronic Graft Versus Host Disease

At regular intervals (the "steps") one cluster (i.e., one site) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Four sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.

Each cluster contributes observations under both control and intervention observation periods.

Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks.

Strength and Balance Training & Nutrition Education

During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises.

Usual Care

There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.

The MoveStrong trial is a 1-year pilot closed cohort stepped wedge randomized control trial (RCT) to evaluate the feasibility of implementation of the MoveStrong program. This program includes a functional exercise and nutrition program that teaches older adults with chronic diseases how to perform functional resistance and balance exercises and promote adequate protein intake and nutrition. Four sites (1 Northern and 3 Southern Ontario sites) will be cluster-randomized to implement MoveStrong at one of four start times, each three weeks apart. The primary outcome will be to determine the feasibility of recruitment and referral from diverse settings (i.e., retirement homes, community centers, and family health teams) and establish the retention and adherence to the program. Secondary objectives will determine the following: What are the participant's and provider's experience with the MoveStrong program? What is the short-term responsiveness (i.e., ability to detect change) of frailty indicators (Fried Frailty Index components), protein intake, or quality of life? Who agrees to participate? What adaptations need to be made to MoveStrong, or study methods in each setting? What is the cost relative to the benefit? Is behaviour change maintained in the maintenance period? Our long term goal is to use the information from this project to develop, implement, and evaluate a sustainable, scalable and pragmatic model to deliver strength and balance training and promote adequate protein intake among older adults with chronic diseases.

We will use a closed cohort stepped wedge design at 4 sites (1 in Northern Ontario and 3 in Southern Ontario). In a stepped wedge, sites are cluster-randomized to implement MoveSTroNg at one of four start times, each three weeks apart.

Functional Exercise and Nutrition Education Program for Older Adults

A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial

If requested we will consider sharing data. If raw data is shared, participant data will be deidentified.

Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.

Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.

Definition: Percentage of individuals that attended exercise and nutrition sessions.

The criterion for success is 70% or higher.

Fried Frailty Index Components: We will measure the change in body weight with a calibrated scale. A change of 5% (greater or lower) in 1 year is considered worse.

Fried Frailty Index Components: walking speed via the 10-meter walk test protocol. A change of 0.05 m/s is considered as a small meaningful change, while 0.13m/s is considered a substantial change.

Fried Frailty Index Components: fatigue/exhaustion via the Center for Epidemiologic Study Depression Scale-Fatigue Questions. The score ranges from 0-60 (higher scores reflect increased symptom severity)

Fried Frailty Index Components: lower physical activity via the CHAMPS Physical Activity Questionnaire for older adults. No score, but the recommended physical activity levels are 150 minutes of moderate to vigorous activity and 2 days of strength training of major muscle groups.

Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer

We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance. Scores range depending on age and sex (e.g., male 60 to 64, \< 14 chair stands is considered below average, while a male 65 to 69, \< 12 is below average).

The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls

The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better.

The EuroQol 5 dimension version 5-level (EQ-5D-5L) also records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). This information can be used as a quantitative measure of health as judged by the individual respondents. A higher score indicates better quality of life

We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section

We will use a semi-structured interview guide to conduct exit interviews with each participant and kinesiologist. Interviews and training sessions will be audio-recorded and transcribed verbatim. Two researchers will perform thematic analyses to describe participant and provider experience and satisfaction, adaptations, and learning needs. There is no scale to this section

We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section

We will use the Productivity and Activity Index questionnaire to assess indirect resource use over the last 6 weeks of the program.There is no scale to this section

We will use the Health Utility Form to assess direct medical resource use over the last 6 weeks of the program. Direct medical costs will be measured using a closed and open-ended survey about their personnel, hospitalization, medications, rehabilitation, and test costs. This questionnaire also evaluates out of pocket expenses and transportation.There is no scale to this section

Canadian Institutes of Health Research (CIHR)

City of Lakes family Health Team

Schlegel Villages and Research Institute for Aging

YMCA

Kinnect to Wellness

University of Waterloo

Ear, Nose, and Throat Diseases

Neoplasms

Digestive System Diseases

Sarcopenia

Peripheral Nervous System Diseases

Vertigo

Dizziness

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Neuromuscular Diseases

Vestibular Diseases

Labyrinth Diseases

Labyrinthitis

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Patients in the intervention groups will receive neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). In addition, all patients will undergo three months' targeted specialized physical group-based exercise and Comprehensive Geriatric Assessment with corresponding interventions

Patients in the usual care groups will receive standard treatment with neoadjuvant, adjuvant or first line palliative chemotherapy (for metastatic disease). If the patients have other health complaints, these will, as current standard procedure, be treated by oncologist or by referral to general practitioner

Vestibular rehabilitation, balance- and progressive resistance training for three months' three times/week and Comprehensive Geriatric Assessement including corresponding interventions

Targeted specialized physical group-based exercise and Comprehensive Geriatric Assessement

Katrine S Piper, PhD-Student

Jan Christensen, PhD

Cecilia M Lund, PhD

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.

The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer

Changes in walking speed using 10 meter walk test measuring gaitspeed in meters per second

Changes in postural control (standing balance) using HUR SmartBalance platform

Changes in peripheral vestibular function using Video Head Impulse Test (vHIT)

Changes in orthostatic blood pressure measured from lying to standing and every minute for five minutes

Changes in body composition using bioimpedance (BIA)

Changes in muscle quality using ultrasound

Presence of frailty using Geriatric-8 (G8) scored on a 0-17 point scale. Higher score means better outcome

Presence of frailty using Clinical Frailty Scale (CFS) scored on a 1-9 point scale. Higher score means worse outcome

Description of activity level using activity tracker

Recording of exercise through a prescribed rehabilitation plan

Biomarkers of sarcopenia and inflammation collected through blood samples. To determine concentration of inflammatory cytokines; High-sensitivity C-reactive Protein (hsCRP), tumour necrosis factor alpha (TNF- α), interleukin 6 (IL6), interleukin 13 (IL-13), and of muscle atrophy and muscle wasting (growth differentiation factor 11 (GDF11), and growth differentiation factor 15 (GDF-15). Blood samples are analysed by standard ELISA-analyses for plasma samples.

Measurement of vision using a Snellen chart

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

Between-group difference in lower limb muscle strength and endurance

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

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

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

Changes in peripheral nerve function using biothesiometer mesured in 0-50 volts. Higher volts means worse outcome

Changes in autonomic function using Vagus device

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

Changes in muscle strength using HUR Leg Press Rehab performance recorder measuring weight in kilograms

Changes in muscle strength using handgrip test measuring weight in kilograms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of a 6-week Balance, Agility, Strengthening Exercise Class	NCT04318574	Neoplasms	Balance, Agilit...	18 Years -	University of Manitoba
Functional Exercise and Nutrition Education Program for Older Adults	NCT04037436	Chronic Disease Frail Diabetes Mellit... Cancer Chronic Lung Di... Cardiovascular ... Congestive Hear... Hypertension Osteoporosis, O... Arthritis Stroke Kidney Diseases	Strength and Ba... Usual Care	60 Years -	University of Waterloo
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer	NCT05710809	Colorectal Canc... Oncologic Compl... Comprehensive G... Vestibular Reha... Geriatric Oncol... Sarcopenia Vertigo Cancer Rehabilitation Exercise Geriatric Elderly Frail Older Adults Chemotherapy Chemotherapy-in... Resistance Trai... Balance Trainin... Postural Stabil... Pragmatic Trial Personal Medici... Individualised	Targeted specia...	65 Years -	Rigshospitalet, Denmark
Functional Exercise and Nutrition Education Program for Older Adults	NCT04037436	Chronic Disease Frail Diabetes Mellit... Cancer Chronic Lung Di... Cardiovascular ... Congestive Hear... Hypertension Osteoporosis, O... Arthritis Stroke Kidney Diseases	Strength and Ba... Usual Care	60 Years -	University of Waterloo

Spots Global Cancer Trial Database for balance training