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The objective of this study is to evaluate if a multi-component exercise intervention is effective at reversing pre-frailty phenotype in females age 65 or older. Participants will be screened for frailty phenotype using the Cardiac Health Study - Frailty Index; the Clinical Frailty Scale; and a measure of self-paced normal walking speed. Participants will undergo baseline evaluation and then be randomized into one of two groups; 1) Multi-component exercise program, or 2) a control group who receives a monthly newsletter on tips for successful aging. The experimental group will participate in multi-component exercise program which will emphasize resistance training but also include aerobic, balance and flexibility components 3 times a week at 45 to 60 minutes/session for 16 consecutive weeks. Control group will be asked to maintain normal living habits for the duration of the study.
railty is term widely used to denote a multidimensional syndrome associated with the loss of physical and cognitive reserve capacity that makes an individual vulnerable to cumulative clinical health conditions (Rockwood et al. 2005). The level of frailty can be classified as one of three phenotypes (non-frail; pre-frail, frail) depending on the number of physical deficits expressed by the individual (Fried et al., 2001). These deficits include (unexplained weight loss, poor grip strength, feelings of exhaustion, slowed gait, and low levels of physical activity). An individual who exhibits 1-2 deficits in physical function suggests a pre-frail phenotype. The Canadian Study of Health and Aging's Clinical Frailty Scale (CFS; Canadian Study of Health and Aging Revised, 2008) classifies older adult's level of frailty as per a 9-point scale ranging from "Very fit" (level 1) to "Terminally Ill" (level 9). An individual is considered vulnerable or mildly frail if they fall between levels 4 and 5 on the CFS. Both assessment tools will be used to assess frailty status. It arguably becomes more difficult to restore physical health once the individual attains 3+ deficits on the CHSS or ≥ level 6 on the CFS.
The purpose of this study is to determine if the pre-frail phenotype can be reversed in participants who are pre-frail and/or vulnerable or mildly frail using CHSS and CFS assessment tools respectively. Both assessment tools are used as both inclusion criteria and as outcome measures within this study. To confirm frailty status, gait speed will be evaluated over 4 meters. A normal gait speed of 1-1.5 meters/second is associated with persons expressing the pre-frailty phenotype. Females are most susceptible to frailty; therefore, this investigation targets females 65 years of age and older. Eligibility criteria includes only females (65+ years) who are considered pre-frail by the CCHS and vulnerable to mildly frail (levels 4-5) on the CFS, with a normal gait speed between 1-1.5 meters/second (m/s). Individuals who are consider pre-frail are highlighted for our study as we believe that this demographic is at a critical-point of physical transition between frailty phenotypes. If pre-frail individuals do not actively engage in restorative exercise to reclaim muscle strength and balance, they will remain as pre-frail or continue to regress toward the frailty phenotype.
Since frailty is a multidimensional geriatric syndrome additional assessment tools will be used to determine physical strengths and deficits within each individual. Participants will be cleared for exercise participation using the Physical Activity Readiness Questionnaire - Plus (PARQ+) and cleared for exercise by a Certified Exercise Physiologist. Certified Exercise Physiologists in good standing with the Canadian Society for Exercise Physiology are trained to effectively screen participants with multiple co-morbidities for exercise and prescribe appropriate exercise programs for the individual. Participants with unstable health conditions will be advised to seek physician approval before re-entering the study using the PAR-Medx assessment form. Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) tool to ensure that participants are not suffering from non-observable cognitive impairment.
Participants will be randomized, using a table of random numbers, to either an Exercise (EX) or a Control (CON) group. The EX group will participate in a 16-week multi-component training intervention (3x per week, 45 to 60 minutes/session, at moderate to vigorous intensity) that will include primarily resistance exercises, an aerobic warm-up and cool down, and include both flexibility and balance exercises throughout the session (Bray et al., 2016). The CON group will be asked to maintain their normal daily living habits for the same duration (16 weeks). At the conclusion of the 16-weeks the exercise program will be made available to the CON group.
This is a feasibility study, thus we have set a sample size goal at 50 participants, 25 per group (EX=25, CON=25). Simple T-tests will be used to analyze intergroup differences at baseline and post intervention. Analysis of Variance (ANOVA) will be used to analyze intragroup differences at week 0 (baseline), week 8 (mid-point) and week 17 (post intervention). Measures of intragroup differences include frailty assessment measures (CHSS and CFS), the Short Physical Performance Battery (SPPB) protocol (Guralnik et al. 1994), muscle strength of the dominate arm and leg using the Biodex levels according to Biodex assessments and daily physical activity accumulation assessed by the Phone FITT (Gill et al. 2008) questionnaire. More information on each of these assessment tools, including their application to the targeted population, validity and time to complete can be found in attachment entitled "Summary of Assessment Tools."
We hypothesize that those who are randomly enrolled into the exercise intervention will reverse their frailty phenotype ('pre-frail' become 'non-frail') and return to lower levels (<4) on the CFS ('vulnerable' become 'managing well'), while those in the control group will be unchanged or further regress in their frailty phenotype, become frail, or move further along the CFS to become moderately frail. This research will provide support for the use of multi-component exercise as a proactive approach to restoring physical independence and quality of life for older adults.
Observational Model: Cohort, Time Perspective: Cross-Sectional
Not yet recruiting
University of British Columbia
Published on BioPortfolio: 2016-11-03T08:08:21-0400
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