Personalized Exercise Programs for Older Adults - a Digital User-friendly Application

NCT04181983 | Completed

• 1 other identifier: JMJYN-HMO-CTIL
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Older Adults; Exercise

Keywords

Home-based personalized exercise program; Smart phone application

Outcome Measures

Primary Outcomes (5)

• Balance

  1. Neutral stance eyes closed 2. Right leg stance 3. Left leg stance 4. Tandem stance right 5. Tandem stance left 6. Tandem walk forward (10 steps) 7. Tandem walk backward (10 steps) All the above will measure: range of acceleration in each direction (anterior-posterior, medio-lateral, superior-inferior) assessed in m/sec2

  Changes in balance will be measured at the following points in time: Pilot study entry and 6 weeks later; Main study T0 (Baseline), T1 (6 weeks), T2 (12 weeks), T3 (18 weeks), T4 ( 24 weeks)

• Balance

  Time-up-and-go: A composite measure of balance , which includes 1) the range of acceleration in each direction (anterior-posterior, medio-lateral, superior-inferior) assessed in m/sec2,2) the Number of steps taken (n), 3) Step length (cm).

  Changes in balance will be measured at the following points in time:Pilot study entry and 6 weeks later; Main study T0 (Baseline), T1 (6 weeks), T2 (12 weeks), T3 (18 weeks), T4 ( 24 weeks)

• Leg Strength

  Sit-to-stand A composite measure of leg strength based upon measurement of number of repetitions in 30 sec (n), and the acceleration range which will be measured in m/sec2

  Changes in leg strength will be measured at the following points in time:Pilot study entry and 6 weeks later; Main study T0 (Baseline), T1 (6 weeks), T2 (12 weeks), T3 (18 weeks), T4 ( 24 weeks)

• Upper extremities flexibility

  1. Rotate torso to right 2. Rotate torso to left 3. Right arm flexion 4. Right arm extension 5. Right arm abduction 6. Right arm to left shoulder at 90◦ 7. Right arm back folded 8. Left arm flexion 9. Left arm extension 10. Left arm abduction 11. Left arm to left shoulder at 90◦ 12. Left arm back folded The above tests are assessed by angle between arm and the horizon.

  Changes in upper extremities flexibility will be measured at the following points in time:Pilot study entry and 6 weeks later; Main study T0 (Baseline), T1 (6 weeks), T2 (12 weeks), T3 (18 weeks), T4 ( 24 weeks)

• Upper extremities strength

  1. Lifting right arm forward 20 times 2. Lifting left arm forward 20 times 3. Lifting right arm to the side 20 times 4. Lifting left arm to the side 20 times For the above tests the range of acceleration will be assessed in m/sec2.

  Changes in upper extremities strength will be measured at the following points in time:Pilot study entry and 6 weeks later; Main study T0 (Baseline), T1 (6 weeks), T2 (12 weeks), T3 (18 weeks), T4 ( 24 weeks)

Study Arms (3)

Personalized exercise program

EXPERIMENTAL

A home-based personalized exercise program using a smartphone app

Other: Personalized exercise program

Active Control WHO guidelines

ACTIVE COMPARATOR

A standard exercise program based upon WHO guidelines

Other: WHO exercise guidelines

Control

NO INTERVENTION

No exercise program

Interventions

Personalized exercise program OTHER

Home-based personalized exercise program using a smart phone app

Personalized exercise program

WHO exercise guidelines OTHER

Standard exercise counselling according to WHO guidelines

Active Control WHO guidelines

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Living place: Home or Independent Living
• Fluent Hebrew speaker
• Ambulatory status: walks independently without help from another person
• Functional status: independent in dressing, toileting, grooming, washing, eating
• Smartphone user

You may not qualify if:

• Cognitive decline \<3/5 on Mini-Cog Score
• Hospitalization ( \>24 hours) or Emergency Room referral in last 12 months due to unstable heart disease (congestive heart disease/rhythm disorder/ischemic heart disease/valvular heart disease) or neurological disease including balance or dizziness (cerebrovascular disease, vestibular disease, progressive neurological disease affecting gait or balance). (Information by self-report on direct questioning).
• High risk of falling (#): Any positive answer to one of the following questions: "Have you fallen over twice or more in the last year?", "Have you fallen and hurt yourself in the last year?", "Are you afraid that you might fall because of balance or walking problems?"
• Unwilling to provide consent.
• (#) 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:
• Strategies to reduce injuries and develop confidence in elders (STRIDE): a cluster-randomized pragmatic trial of a multifactorial fall injury prevention strategy: design and methods. Bhasin S et al. Journal of Gerontology A Biological Science Medical Science,2018;73:1053-1061
• Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the Lifestyle integrated Functional Exercise (LiFE) study): randomized parallel study. Clemson L at al. British Medical Journal 2012;345:e547

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Zinman College of Physical Education and Sports Sciences: collaborator

Study Sites (1)

Hadassah medical Organization

Jerusalem, Israel

Location

Related Publications (1)

• Netz Y, Argov E, Yekutieli Z, Ayalon M, Tchelet K, Ben-Sira D, Amar Y, Jacobs JM. Personalized multicomponent exercise programs using smartphone technology among older people: protocol for a randomized controlled trial. BMC Geriatr. 2021 Oct 26;21(1):605. doi: 10.1186/s12877-021-02559-2.

  PMID: 34702168 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jeremy M Jacobs, MBBS BSc

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: December 2, 2019
• Study Start: October 27, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)