Fall Clinical Trial
Official title:
The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face in Low-medium Risk Elderly- A Cross Over Randomized Controlled Trial
Verified date | August 2022 |
Source | University of Haifa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Falls are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large. This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. This study design is a randomized control trial (RCT) with a cross-over in group allocation. The population will include 106 home-dwelling elderly, aged 65 years or more, with low to moderate risk of fall. Participants will be randomized to start intervention in the remote or face-to-face group. Training will be twice weekly for 3 months, after which there will be two weeks of washout, followed by a cross-over between groups. Outcome measures will include fall rate over a year (primary measure), balance, functional testing, subjective measures of fear of falls, quality of life, satisfaction from intervention, adherence, and compliance.
Status | Completed |
Enrollment | 81 |
Est. completion date | March 26, 2023 |
Est. primary completion date | March 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - home-dwelling elderly, aged 65 years or more - Identified to be at low to moderate risk of falling Risk of falling will be assessed according to a combination of subjective and objective evaluation. Subjective questions from the STEADI (stopping elderly accidents death, and injuries), an algorithm for fall risk screening, assessment, and intervention, developed by the American Center for Disease Control and Prevention, relate to (1) Feels unsteady when standing/walking, (2) Worries about falling, and (3) Has fallen no more than 3 times in the past year. An additional inclusion criterion is scoring 21 or more in the Mini-Best test (a balance test). Exclusion Criteria: - Subjects suffering from severe musculoskeletal pain or disorders that will limit completion of the assessment procedure such as pain limiting weight-bearing for no longer than a few minutes - Unstable cardiovascular/pulmonary disease - Unbalanced diabetes - Neurological diseases such as stroke, Parkinson's, or multiple sclerosis - Use of a walking aid (except for a cane) - visual or hearing impairment that will not allow the use of technology for remote practice - A score lower than 21/30 on the Montreal Cognitive Assessment score (MoCA), - High risk of falling on the balance test (Mini-BESTest = 20) Comment: exclusion criteria will be based on self-report and completed at the initial baseline assessment |
Country | Name | City | State |
---|---|---|---|
Israel | The Faculty of Social Welfare and Health Science, Haifa University | Haifa | |
Israel | Gold club Kfar vradim | Kfar vradim |
Lead Sponsor | Collaborator |
---|---|
University of Haifa | Western Galilee Hospital-Nahariya |
Israel,
Bernocchi P, Giordano A, Pintavalle G, Galli T, Ballini Spoglia E, Baratti D, Scalvini S. Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):340-346. doi: 10.1016/j.jamda.2018.09.003. Epub 2018 Oct 23. — View Citation
Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11. — View Citation
Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of falls during the study period | Subjects will self-report falls weekly in a personal fall diary. This will be supported by a telephone call from one of the investigators once a month. | Falls will be monitored for one year | |
Secondary | Mini Balance Evaluation Systems Tests | Mini Balance Evaluation Systems Tests (Mini-BESTest) is a clinical balance assessment tool. This test includes 14 items, each scored from 0 (severe balance impairment) to 2 (no balance impairment). The maximal possible score is 28 points. Higher scores indicate better balance performance. A score of 20 points or below indicates a high fall risk. | Change from baseline at 3, 6 and 12 months | |
Secondary | Time-Up and Go Test | The Timed Up and Go Test (TUG) assesses mobility, balance, and fall risk in older adults. The test measures the time required for a subject to stand up from sitting on a chair, walk for 3 meters, turn, walk back, and sit down. A score of 12 seconds or more indicates risk of falling in community dwelling adults. | Change from baseline at 3, 6 and 12 months | |
Secondary | Berg Balance Scale | The Berg Balance Scale (BBS) is a 14- item objective measure that assesses static and dynamic balance, and fall risk in adults. Each item is scored from 0 (unable to perform) to 4 (normal performance). The maximal possible score is 56 points. Any score from 0 to 36 indicate 100% fall risk for older adults. The Berg Balance Scale (BBS) is widely used in clinical practice to predict falls in the older adults. lately, due to ceiling effect, the use of BBS as a single measure to accurately predict future falls seems to be insufficient. | Change from baseline at 3, 6 and 12 months | |
Secondary | Four Stage Balance Test | The 4-Stage Balance Test assess static balance at four standing positions, that get progressively harder to maintain. The person is asked to hold a position for 10 seconds without moving his feet or supporting. An older adult, who cannot hold the tandem stand, which is the forth position, for at least 10 seconds, is at increased risk of falling. | Change from baseline at 3, 6 and 12 months | |
Secondary | Walking speed | Walking speed will be measured using the 4-Meter Walk Test in seconds. Walking speed lower than 1.0 seconds/meter is considered a strong predictor of falls in the elderly population living in the community. | Change from baseline at 3, 6 and 12 months | |
Secondary | Lower extremities functional strength | Functional strength of the lower limbs will be measured by the 30-second Sit to Stand Test. This is also used for fall prediction. A result lower than expected by age and sex indicates a risk of falls | Change from baseline at 3, 6 and 12 months | |
Secondary | Attendance | Attendance to the program will be recorded each class by the physiotherapist who will conduct the training. Total attendance will be defined as the number/percentage of classes attended out of the total number of sessions conducted, for example attending 75 sessions out of 100 will be calculated as total attendance of 75%. | Will be monitored and record in any session time, for 6 months | |
Secondary | Completion (retention) | Completion of the full period of the program- 6 months, will be recorded for each participant, and will reflect retention. Non-completion will be recorded for the participants who will withdrawal from the program before the end of the program, and will not complete the 6 months, end of program, assessment. | Will be monitored and record in any session time, for 6 months | |
Secondary | Satisfaction from program | Participant satisfaction will be assessed using a satisfaction rating scale of 0-10, with a score of 0 indicating complete dissatisfaction and a score of 10 maximum satisfaction. | Twice- after each program session (after 3 and 6 months). | |
Secondary | Fear of falls | Fear of falls will be assessed using the Modified Falls Efficacy Scale (MFES) questionnaire, which is one of the most common and reliable research tools in fall research. In this questionnaire, the subject rates his confidence in performing 10 daily tasks | Change from baseline at 3, 6 and 12 months | |
Secondary | 12-Item Short Form Survey (SF-12) Quality of life questionnaire | Quality of life will be assessed using the SF-12 questionnaire. This questionnaire assesses the perception of quality of life through 12 questions that relate to the subject's views about his state of health and ability to perform various actions and functions. The use of this questionnaire is common in fall studies. | Change from baseline at 3, 6 and 12 months |
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