Dawn P. Gill

Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD

Objective To determine the feasibility and efficacy of a six-month, cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation. Methods Participants who completed a two-week run-in were randomly assigned to either MOBILE-Coached (n = 9) or MOBILE-Self-Monitored (n = 8). All participants met with a nurse to develop an individualized exercise plan, were issued a pedometer and exercise booklet, and instructed to continue to log their daily exercise and symptoms. MOBILE-Coached also received weekly reinforcement text messages on their cell phones; reports of worsening symptoms were automatically flagged for follow-up. Usability and satisfaction were assessed. Participants completed incremental cycle and six minute walk (6MW) tests, wore an activity monitor for 14 days, and reported their health-related quality of life (HRQL) at baseline, three, and six months. Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18% predicted. Participants reported that logging their exercise and symptoms (FEV1) of 40 ± was easy and that keeping track of their exercise helped them remain active. There were no differences between groups over time in maximal workload, 6MW distance, or HRQL (p > 0.05); however, MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months (p =0.04). Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring. The latter finding needs to be interpreted with caution since this was a purely exploratory study. Trial registration ClinicalTrials.gov (NCT00373932).

Using a single question to assess physical activity in older adults: a reliability and validity study

BackgroundSingle-item physical activity questions provide a quick approximation of physical activity levels. While recall questionnaires provide a more detailed picture of an individuals level of physical activity, single-item questions may be more appropriate in certain situations. The aim of this study was to evaluate two single-item physical activity questions (one absolute question and one relative question) for test-retest reliability, convergent validity, and discriminant validity, in a sample of older adults.MethodsData was obtained from the Project to Prevent Falls in Veterans, a fall risk-factor screening and modification trial. One question measured absolute physical activity (seldom, moderately, vigorously active) and one measured relative physical activity (more, about as, less active than peers). Test-retest reliability was examined using weighted Kappa statistics (κ) in a sample of 43 subjects. Validity was assessed using correlation coefficients (r) in participants who received clinical assessments (n = 159).ResultsThe absolute physical activity question was more reliable than the relative physical activity question (κ = 0.75 vs. κ = 0.56). Convergent validity, however, was stronger for the relative physical activity question (r = 0.28 to 0.57 vs. r = 0.10 to 0.33). Discriminant validity was similar for both questions. For the relative physical activity question, there was moderate agreement when this question was re-administered seven days later, fair to moderate/good associations when compared with indicators of physical function, and little to no associations when compared with measures hypothesized to be theoretically not related to physical activity.ConclusionsThe relative physical activity question had the best combination of test-retest reliability, convergent validity and discriminant validity. In studies requiring a measure of physical activity, where physical activity is not the primary focus and more detailed measures are not feasible, a single question may be an acceptable alternative.

Mobile health, exercise and metabolic risk: a randomized controlled trial

BackgroundIt was hypothesized that a mobile health (mHealth) intervention would elicit greater improvements in systolic blood pressure and other cardiometabolic risk factors at 12xa0weeks, which would be better maintained over 52xa0weeks, compared to the active control intervention.MethodsEligible participants (≥2 metabolic syndrome risk factors) were randomized to the mHealth intervention (nu2009=u200975) or the active control group (nu2009=u200974). Blood pressure and other cardiometabolic risk factors were measured at baseline and at 12, 24 and 52xa0weeks. Both groups received an individualized exercise prescription and the intervention group additionally received a technology kit for home monitoring of biometrics and physical activity.ResultsAnalyses were conducted on 67 participants in the intervention group (aged 56.7u2009±u20099.7xa0years; 71.6% female) and 60 participants in the active control group (aged 59.1u2009±u20098.4xa0years; 76.7% female). At 12xa0weeks, baseline adjusted mean change in systolic blood pressure (primary outcome) was greater in the active control group compared to the intervention group (-5.68xa0mmHg; 95% CI -10.86 to -0.50xa0mmHg; pu2009=u20090.03), but there were no differences between groups in mean change for secondary outcomes. Over 52-weeks, the difference in mean change for systolic blood pressure was no longer apparent between groups, but remained significant across the entire population (time: pu2009<u20090.001).ConclusionsIn participants with increased cardiometabolic risk, exercise prescription alone had greater short-term improvements in systolic blood pressure compared to the mHealth intervention, though over 52xa0weeks, improvements were equal between interventions.Trial registrationClinicalTrials.gov http://NCT01944124

Validation of the StepWatch device for measurement of free-living ambulatory activity in patients with chronic obstructive pulmonary disease.

This study examined the validity of the StepWatch activity monitor and the optimal number of monitoring days in patients with chronic obstructive pulmonary disease (COPD). StepWatch activity data were obtained from databases of two studies: one of patients with COPD who participated in a trial of two exercise persistence interventions (n = 17) and a second, cross-sectional study of activity in chronically healthy older adults (n = 60). Independent t tests, Pearson’s correlations, and Bland-Altman plots were used to examine the activity data (total steps, activity intensity, and distribution of activity). Results indicated that patients with COPD registered 50% fewer total steps and had lower levels of walking intensity compared with chronically healthy older adults. Activity parameters had moderate-to-high correlations with disease severity, peak cycle workload, and physical functioning. More monitoring days were associated with greater measurement precision. This study provides preliminary evidence to support the validity of the StepWatch device for measuring free-living ambulatory physical activity in COPD.

A lifestyle intervention supported by mobile health technologies to improve the cardiometabolic risk profile of individuals at risk for cardiovascular disease and type 2 diabetes: study rationale and protocol

BackgroundMetabolic syndrome is a cluster of cardiovascular risk factors that greatly increase the risk of developing cardiovascular disease and type 2 diabetes. Regular exercise improves the risk profile, but most people do not successfully change their exercise habits to beneficially reduce risk. Tailored exercise prescribed by a family physician has shown promise as a means to increase fitness and reduce cardiometabolic risk, but optimal implementation practices remain unknown. Mobile health technologies have proved to be a beneficial tool to achieve blood pressure and blood glucose control in patients with diabetes. These technologies may address the limited access to health interventions in rural and remote regions. However, the potential as a tool to support exercise-based prevention activities is not well understood. This study was undertaken to investigate the effects of a tailored exercise prescription alone or supported by mobile health technologies to improve metabolic syndrome and related cardiometabolic risk factors in rural community-dwelling adults at risk for cardiovascular disease and type 2 diabetes.Methods/DesignAdults (nu2009=u2009149) with at least two metabolic syndrome risk factors were recruited from rural communities and randomized to either: 1) an intervention group receiving an exercise prescription and devices for monitoring of risk factors with a smartphone data portal equipped with a mobile health application; or 2) an active control group receiving only an exercise prescription. All participants reported to the research centre at baseline, and at 12-, 24- and 52-week follow-up visits for measurement of anthropometrics and blood pressure and for a blood draw to test blood-borne markers of cardiometabolic health. Vascular and autonomic function were examined. Fitness was assessed and exercise prescribed according to the Step Test and Exercise Prescription protocol.DiscussionThis study tested the effects of a prescriptive exercise intervention alone, versus one supported by mobile health technology on cardiometabolic risk factors. The intervention was designed to be translated into clinical or community-based programming. Results will contribute to the current literature by investigating the utility of mobile health technology support for exercise prescription interventions to improve cardiometabolic risk status and maintain improvements over time; particularly in rural communities.Trial registrationClinical trials registration: NCT01944124

Differences in rate of functional decline across three dementia types

The purpose of this study was to estimate differences in rates of functional decline in Alzheimers disease (AD), dementia with Lewy bodies (DLB), and vascular dementia (VaD) and whether differences vary by age or sex.

Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial

BackgroundStudies have evaluated the concomitant use of hyaluronan (HA) with steroids, anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis. To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms – one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection. The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations, Hydros (hyaluronan-based hydrogel suspended in hyaluronan solution) and Hydros-TA (HA plus 10 mg of triamcinolone acetonide [TA]) in subjects with knee osteoarthritis.MethodsWe conducted a Phase 2 prospective, multicenter, randomized, double-blind feasibility trial. Participants (nu2009=u200998; mean age 60xa0years) with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to three treatment groups: Hydros, Hydros-TA, and Synvisc-One® (hylan G-F 20). Participants received one 6xa0ml intra-articular injection in the treatment knee and were evaluated at 2, 6, 13, and 26xa0weeks post-treatment. Safety was assessed from adverse events at all study visits. The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (Pain) score for the treatment knee.ResultsAdverse events were similar across treatment groups with the most common being arthralgia, joint swelling, back pain, and joint stiffness. Arthralgia was reported 5 times with Synvisc-One, 4 with Hydros, and 1 with Hydros-TA. Each group demonstrated a reduction in the WOMAC A (Pain) score over 26xa0weeks: [least-square mean (standard error)] 30.5 (5.1) mm for Hydros; 34.4 (4.7) mm for Hydros-TA; 28.0 (5.4) mm for Synvisc-One and an observed improvement of 2.5xa0mm (pu2009=u20090.64) and 6.4xa0mm (pu2009=u20090.24) over Synvisc-One for Hydros and Hydros-TA, respectively.ConclusionsA single injection of Hydros or Hydros-TA was well-tolerated and relieved pain associated with knee osteoarthritis over 26xa0weeks. Data indicate that Hydros-TA had a more rapid pain relief compared to Hydros alone. A Phase 3 trial is underway to confirm these preliminary results.Trial registration numberNCT01134406.

Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol

BackgroundDementia is associated with cognitive and functional deficits, and poses a significant personal, societal, and economic burden. Directing interventions towards older adults with self-reported cognitive complaints may provide the greatest impact on dementia incidence and prevalence. Risk factors for cognitive and functional deficits are multifactorial in nature; many are cardiovascular disease risk factors and are lifestyle-mediated. Evidence suggests that multiple-modality exercise programs can provide cognitive and functional benefits that extend beyond what can be achieved from cognitive, aerobic, or resistance training alone, and preliminary evidence suggests that novel mind-motor interventions (i.e., Square Stepping Exercise; SSE) can benefit cognition and functional fitness. Nevertheless, it remains unclear whether multiple-modality exercise combined with mind-motor interventions can benefit diverse cognitive and functional outcomes in older adults with cognitive complaints.Methods/DesignThe Multiple-Modality, Mind-Motor (M4) study is a randomized controlled trial investigating the cognitive and functional impact of combined physical and cognitive training among community-dwelling adults with self-reported cognitive complaints who are 55xa0years of age or older. Participants are randomized to a Multiple-Modality and Mind-Motor (M4) intervention group or a Multiple-Modality (M2) comparison group. Participants exercise for 60xa0minutes/day, 3-days/week for 24xa0weeks and are assessed at baseline, 24xa0weeks and 52xa0weeks. The primary outcome is global cognitive function at 24xa0weeks, derived from the Cambridge Brain Sciences computerized cognitive battery. Secondary outcomes are: i) global cognitive function at 52xa0weeks; ii) domain-specific cognitive function at 24 and 52xa0weeks; iii) mobility (gait characteristics under single and dual-task conditions and balance); and 3) vascular health (blood pressure and carotid arterial measurements). We will analyze data based on an intent-to-treat approach, using mixed models for repeated measurements.DiscussionThe design features of the M4 trial and the methods included to address previous limitations within cognitive and exercise research will be discussed. Results from the M4 trial will provide evidence of combined multiple-modality and cognitive training among older adults with self-reported cognitive complaints on cognitive, mobility-related and vascular outcomes.Trial RegistrationClinicalTrials.gov NCT02136368.

Risk of decline in functional activities in dementia with Lewy bodies and Alzheimer disease.

We examined the risk of 1-year decline in 4 everyday activities in patients with dementia with Lewy bodies (DLB), relative to patients with Alzheimer disease (AD). Data were from the National Alzheimers Coordinating Center, gathered from 32 Alzheimers Disease Centers. Participants (n=1880) were: aged 60+ years, demented with a primary clinical diagnosis of probable AD or DLB, and had a global Clinical Dementia Rating of 0.5 to 2. The activities were measured with the Functional Activities Questionnaire. In modified Poisson regression models adjusted for demographics, baseline activity, years from symptom onset, cognitive impairment, and comorbidities; DLB participants aged 67 to 81 years had 1.5 to 2 times increased risk of decline in performing basic kitchen tasks, engaging in games/hobbies, and paying attention/understanding, relative to AD participants of the same age (P<0.05). There was no significant difference between AD and DLB participants beyond this age range. For decline in ability to go shopping alone, there was also no significant difference between AD and DLB participants. In summary, the functional course of DLB, relative to AD, may depend on the age of the patient. These findings may provide anticipatory guidance to families and healthcare providers, which may be useful in the planning of care strategies.

Early MCI as an imaging target: Data from the National Alzheimer's Coordinating Center

also excluded. The present study therefore included 337 subjects of whom 13 had developed AD (NINCDS-ADRDA criteria) and 25 SD (according to criteria of Erkinjuntti et al). MRI scans at 3 year follow-up were compared between groups. The CC was semi-automatically outlined on MRI images and quantified at baseline and follow-up. ARWMCs were visually scored using Fazekas scale (mild, moderate, severe) at baseline. Total CC area at follow-up was entered into ANCOVA analysis to test for differences between groups (AD, SD, non-demented). Subregional differences were analysed using repeated-measures ANCOVA, and significant results were further examined using univariate analysis. Results: Groups differed with regards to age, ARWMC-load and gender. Therefore the variables were entered into the ANCOVA analysis as covariates. AD, SD and non-demented elderly subjects did not differ in total CC area. AD and SD patients had smaller CC1 and CC5 compared to non-demented elderly subjects at 3 year follow-up, but did not differ in other CC subregions. No difference in subregional areas between the 2 patient groups. Conclusions: The presented results indicate that anterior and posterior CC atrophy is associated with dementia. No specific atrophy pattern was identified in dementia subtypes, although this may have been due to the relatively small number of subjects who developed dementia.