University of Toronto
Toronto, Ontario, M5S 2C9, Canada
Location status: Recruiting
Location contact
Amy A. Kirkham, PhD
CONTACT
Jenna B. Gillen, PhD
CONTACT
NCT Number: NCT06454864
This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:
* What is the impact of exercise on cardiometabolic health and body composition in BC survivors? * What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition? * Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors?
The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.
Interested in participating?
Request InfoFemale
Interventional
Not applicable
Toronto, Ontario, M5S 2C9, Canada
Location status: Recruiting
Amy A. Kirkham, PhD
CONTACT
Jenna B. Gillen, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.
Through a combination of exercise trainer-led in-person and virtual sessions, as well as counselling for independent aerobic exercise, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.
Twice weekly virtual instructor-led whole-body stretching.
Time frame: 6 months
As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).
Time frame: 6 months
Indirectly measured via HOMA-IR using fasting glucose and insulin levels
Time frame: 6 months
Calculated as a z-score to allow for tracking change in the interventions
Time frame: 6 months
Calculated using a widely-used standardized scoring system
Time frame: 6 months
Measured as peak volume of oxygen consumption via indirect calorimetry during a cardiopulmonary exercise test on a treadmill.
Time frame: 6 months
Measured as the difference between peak heart rate during the cardiorespiratory fitness test and heart rate 2-minutes after stopping the exercise test.
Time frame: 6 months
Calculated as the VO2 from the corresponding workload from the day 1 treadmill test divided by cardiac output at rest, submaximal, and maximal periods of the treadmill test
Time frame: 6 months
Measured as the average of the last 5 of 6 blood pressure measurements using an automatic blood pressure device.
Time frame: 6 months
Measured as thigh muscle fat fraction (percent of muscle compartment composed of fat pixels) determined from contiguous axial fat-water separation 3T magnetic resonance images of both thighs.
Time frame: 6 months
Measured using an isokinetic dynamometer (Biodex) to assess peak torque and total work in 30 repetitions of knee flexion.
Time frame: 6 months
Measured determined from contiguous axial fat-water separation 3T magnetic resonance images of both thighs
Time frame: 6 months
Measured via western blotting from a skeletal muscle biopsy of the vastus lateralis muscle. Proteins of interest include those found in mitochondria, contractile signaling pathways, insulin signaling pathways, and in glucose and fat metabolism.
Time frame: 6 months
Measured via immunofluorescence from a skeletal muscle biopsy of the vastus lateralis muscle. Outcomes of interest will focus on indicators of histology of the skeletal muscle in withc a stain would include skeletal muscle capillarization, lipid content, and fiber type and cross-sectional area.
Time frame: 6 months
Measured via spectrophotometer to assess the maximal enzyme activity of enzymes involved in skeletal muscle oxidative capacity, from a biopsy of the vastus lateralis muscle.
Time frame: 6 months
Measured using a body composition device (BodPod) to estimate whole body fat (in kg and %) and fat free mass (in kg and %).
Time frame: 6 months
Volumes of adipose tissue in the visceral region measured using 3T fat-water separation magnetic resonance imaging
Time frame: 6 months
Measured as percent of liver volume composed of fat pixels determined from 3 slices through the middle of the liver using the PROFIT1 3T magnetic resonance images sequence.
Time frame: 6 months
Circumferences of the waist, hip and neck, measured using an inelastic tape
Time frame: 6 months
Analyzed from blood serum using a clinical assay at a core lab.
Time frame: 6 months
Analyzed from blood plasma using a clinical assay at a core lab.
Time frame: 6 months
Various components of dietary intake including macronutrients and micronutrients will be assessed through 3-day food records over 2 weekdays and 1 weekend collected using ASA-24 online system.
Time frame: 6 months
Assessment of ALT, AST, and albumin via a fasting blood serum draw, analyzed on a clinical assay at a core lab.
Time frame: 6 months
Liver T1 time evaluated using the PROFIT1 magnetic resonance sequence, validated marker of liver fibrosis.
Time frame: 6 months, 12 months
Average adherence to prescribed aerobic physical activity weekly minutes measured via Garmin smartwatch
Time frame: 6 months, 12 months
Average adherence to prescribed resistance exercise activity weekly sessions via an attendance log
Time frame: 3 months, 6 months, 12 months
An overall measure of alignment with the dietary guidelines measured via the Healthy Eating Food Index-2019 calculated from 3-day diet records
Time frame: 3 months, 6 months, 12 months'
Assessed by RAND-36, where an independent score is provided for 8 scales ranging from 0 to 100 and 2 component summary scales ranging from 0-50 with a higher score indicating better quality of life.
Time frame: 3 months, 6 months, 12 months'
Assessed by EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Time frame: 3 months, 6 months, 12 months'
Assessed by the perceived stress scale (PSS-14) where individual scores can range from 0 to 56 with higher scores indicating higher perceived stress
Time frame: 3 months, 6 months, 12 months'
Measured by the Hospital Anxiety and Depression Scale (HADS); score ranges from 0-21 for each of depression and anxiety with a higher score indicating more severe depression or anxiety
Time frame: 3 months, 6 months, 12 months'
Assessed by the barriers to self-efficacy scale (BARSE). For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Time frame: 3 months, 6 months, 12 months'
Assessed via the multi-process action control approach, which is a series of questionnaires developed to understand affective attitudes, instrumental attitudes, perceived capability over physical activity, perceived opportunity for physical activity, decisional intentions, behavioural regulation, physical activity habits, and identity around physical activity. Higher scores represent better physical activity motivations. (Reference: Rhodes, R.E. (2017). The evolving understanding of physical activity behavior: A multi-process action control approach. In A. J. Elliot (Ed), Advances in Motivation Science. (pp. 171-205).)
Time frame: 3 months, 6 months, 12 months'
Subjectively assessed by the Pittsburgh Sleep Quality Index (PQSI), which measures components of sleep: sleep duration, disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use, with higher scores reflecting poorer sleep quality.
Time frame: 3 months, 6 months, 12 months'
Measured via Garmin smartwatch for the total sleep duration and efficiency.
Time frame: 3 months, 6 months, 12 months'
Assessed by the Recent Physical Activity Questionnaire (RPAQ) that collects information about types and amounts of activity (sedentary and physical activities) over the last 3 months in the following domains: leisure time, occupation, commuting, domestic life, with greater scores indicating longer time engaging in forms of activity.
Time frame: 6 months
Assessed using a fasting blood plasma sample in a clinical assay at a core lab.
Time frame: 6 months
Assessed using fasting blood serum in a clinical assay.
Time frame: 6 months
Assessed using a calibrated scale attached to the BodPod body composition device.
Time frame: 6 months
Calculated from a measurement of height using a stadiometer and body weight (detailed above).
Time frame: 6 months
Energy balance will be quantified as: 3-day avg calorie intake - [estimated resting metabolic rate + 3-day avg Garmin estimate of physical activity energy expenditure + 10% of calorie intake (thermic effect of food)].
Time frame: baseline, 3 months, 6 months, 12 months'
Assessed using the Multidimensional Fatigue Inventory (MFI-20), a 20-item self-assessment questionnaire that uses a 1 to 5 scale to indicate how statements regarding fatigue are representative of a respondent's experience. A higher score is indicative of higher levels of fatigue.
Time frame: baseline, 3 months, 6 months, 12 months'
The online CANRISK tool (www.healthycanadians.gc.ca/en/canrisk) assigns scores to risk factors for type 2 diabetes (that overlap with cardiovascular disease/cancer), including age, body mass index, MVPA, fruit/vegetable intake, hypertension, pregnancy complications, ethnicity and education, and is validated for Canada's multiethnic population.
Contact information is provided by the study sponsor or research team.
Amy A Kirkham, PhD
CONTACT
Jenna B Gillen, PhD
CONTACT
University of Toronto
Other
Acronym: MsFITBC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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