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Scientific Background:
Despite the known health benefits of exercising during old age, older people remain highly sedentary. Official exercise guidelines aimed specifically at older people focus primarily on aerobic activity, and tend to be over generalized.There is need for personalized exercise programs, which account for the increasing variability in measures of fitness and mobility with advancing age, and offer exercises aimed at improving balance, strength, flexibility and aerobic fitness, and which can be performed at home. Advancing smartphone technology provides tools which might help address this important area of public health.
Study Aims:
To develop a novel digital smartphone app, which enables assessment of fitness components, and provides personalized comprehensive exercise programs which update at regular intervals according to changes in fitness levels.
Methodology:
A prospective interventional randomized control study involving 360 people aged ≥65 living at home/ sheltered living. Stage 1 will include selecting exercise and fitness tests, developing a smartphone app for self-assessment of these tests, and designing exercise programs to meet specific capabilities. A pilot study (n=60) will validate results from the app compared to standard laboratory tests, before finalizing the study platform, and will create a platform for matching exercise programs to levels of fitness. At Stage 2 - the main study - participants (n=300) will be randomly assigned to the intervention group (personalized updating exercise program via the app), an active control group (receiving World Health Organization (WHO) exercise guidelines), or control group (no intervention). Using the app for assessment, all participants will be tested during stage 2 at T0 (baseline), T1 (6 week) T2 (12 weeks), and during Stage 3 follow-up at T3 (18 weeks) and T4 (24 weeks).
Novelty and Applicability:
This innovative technology will enable older people to test their fitness level, and receive a personalized exercise program based on their current ability and preferences, which changes over time according to their progress. The program will be presented as photos and short videos, available on their smartphones, or easily transferable to computer or television (TV) screens.
Full description
1.1 Scientific Background
Although the health benefits of exercise among the elderly are accepted, there is a need for greater accuracy in assessment of a wide range of fitness and mobility parameters, in order to provide a comprehensive exercise program delivered in the home environment. Advances in smartphone technology may provide useful tools to help address this important area of public health.
1.2 Research Objectives
Aim: 1) To examine whether an individually prescribed personalized comprehensive physical activity program performed at home, based on individual motor and physical evaluation, performed by a standard smartphone at home, is more effective than accepted standardized recommendations from the World Health Organization for physical activity, among people aged 65 years and above. The prescribed program will include colorful, clear pictures and videos of various exercises, presented in a user-friendly manner on the user's smartphone, TV or computer screen.
Aim: 2) To enable the personalized exercise program to be updated (by the study exercise specialists), according to the changes in level of fitness, as measured by home testing using the smartphone.
Aim: 3) The ultimate goal of the program is to improve health of older people by increasing the level of physical activity in a safe, enjoyable and effective manner.
1.3 Research Design and Methods
We will employ an interventional, prospective randomized control study.
Ethical Approval: The study has been approved by the Hadassah Hospital Ethics Committee.
Participants:The study population will include a total of 360 community dwelling adults aged ≥65 years, without significant cognitive impairment, (60 adults in the Pilot Study, and a subsequent 300 adults in the Phase II main study).
Recruitment: Recruitment will be by flyers and lectures by the study PI's, at local elderly clubs, day centers, and independent living facilities (retirement homes).
Informed Consent: Informed consent will be attained following a detailed explanation given by the study physician experienced in geriatrics/exercise medicine (either the PI Prof Jacobs or Co Investigator-to be announced closer to the study initiation) concerning study details and any possible medical complications caused either directly (e.g. risk of falls and fractures, musculoskeletal pains, strained ligaments) or secondary to the exercise programs (e.g. cardiac arrhythmias or angina).
Study Procedure and design of research tools:
A. Phase I: Preliminary preparations and a pilot study:
B. Phase II: Main Study lasting 12 weeks:
Study participants (n=300) from day care centers, elderly clubs, retirement villages, etc., will be randomly assigned to 3 groups:
Participants from all groups will be tested individually by the tests app before (T0), after 6 weeks (T1), and after 3 months (T2).
C. Phase III: Follow-up:
The experimental group and the active control group will be re-assessed 6 weeks (T3) and 3 months (T4) following the termination of Phase II. The control group will get the treatment at that point, if they so desire.
Sample Size and Power Analysis: Statistical power was calculated using G * Power. Based on a 2-way ANOVA (3 groups X 5 tests) with repeated measures on the tests factor, 100 participants in each subgroup enable detecting group differences in statistical power of >99% for a moderate (Cohen's f = .25) and large (Cohen's f = .4) effect size. In addition, the statistical power for detecting differences between repeated measures, and in the interaction between groups in the repeated measures is higher than 99% in the moderate effect size as well as in the high effect size.
D. Additional Data Collection:
Study hypotheses
Statistics: the selected digital tests for assessing the fitness components are to be determined in the first study phase. It is likely that a two-way Analysis of Variance (ANOVA, 3 groups X 5 measurements) with repeated measures on the measurements factor will be applied in most tests. Fisher Least Significant Difference will be used for post-hoc analyses. Significance level for all statistical tests will be set at alpha = .05.
1.4 Equipment and Films of exercises: The new exercises created for the current study will be photographed and/or filmed for video at the laboratory of education technology at the Wingate College.
Laboratory testing:
In order to establish the validity of the new dedicated mobile phone tests, participants of the pilot study will be tested on gold standard measurements at the biomechanical, physiological and motor control laboratories at the Wingate College. The laboratories are equipped with the following devices: Vicon Motion Capture Systems for 3D motion analysis (gait analysis and postural control), Biodex Medical Systems for isokinetic force measurements (strength of upper and lower extremities), motorized treadmill -Woodway, Germany (cardiovascular fitness - predicted VO2), and Balance Tutor (postural control, static and dynamic balance).
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Inclusion and exclusion criteria
Inclusion Criteria (all must be positive for inclusion)
Exclusion Criteria (any positive for exclusion)
(#) The identification of subjects at risk of falling will be based upon these three validated questions to identify and screen for increased risk of falling, used in community based exercise intervention and fall prevention studies:
Primary purpose
Allocation
Interventional model
Masking
239 participants in 3 patient groups
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Central trial contact
Jeremy M Jacobs, MBBS BSc; Hadas Lemberg, PhD
Data sourced from clinicaltrials.gov
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