Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fall prevention programe.
- Who it may be relevant to
- Registry conditions: Fall, Osteo Arthritis Knee, Total Knee Replacement. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kuwait
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Short- and Long-term Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement: a Pragmatic Single-blinded Randomized Controlled Trial.
Overview
the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.
Detailed description
Falls constitute a serious and common threat to the health and well-being of older individuals, and this threat increases with aging. Falls in older individuals place a significant burden on the health care system as well as the caregivers (i.e., family). Importantly, however, many falls could be prevented.
Osteoarthritis (OA) of the knee is a common degenerative musculoskeletal condition among elderly that results in ambulatory dysfunction. This progressive degenerative disorder is usually associated with pain, muscle weakness, and poor balance, all of which are considered primary risk factors for falling among older adults. Total knee replacement (TKR) is the most replicable and effective orthopaedic procedure used to treat advanced-stage knee OA. The goal of TKR is to relieve pain, increase knee mobility, and improve functional ability and the overall quality of life. Despite the promising results of TKR surgery, it is associated with a high prevalence of falls. In this regard, falls rate have been reported to be between 6.2% and 42.6% in the first 12 months following TKR. Persistence of muscle weakness and poor balance may contribute to the high fall rate following TKR. This highlights the importance of targeting muscle strength and balance during rehabilitation, considering the short-term implications that could reflect on long-term recovery.
A substantial amount of evidence supports the use of exercise-based interventions (i.e., muscle strengthening and balance training) to prevent falls and fall-related injuries. A Cochrane systematic review by on 108 RCTs (n=23,407) provided high-certainty evidence that exercises, particularly balance and functional based-exercises, are more effective in reducing the falls rate compared to the control interventions. Moreover, exercise-based interventions have been shown to be superior to other interventions for mitigating age-related decline and reducing falls and falls-related injuries with the least harm and greatest cost-effectiveness.
Conventional physiotherapy following TKR involves, primarily, strengthening and knee range of motion exercises and gait re-education. However, there is a lack of balance training/exercises in the rehabilitation program. Given the high prevalence of falls following TKR, integrating a comprehensive fall prevention program into conventional physiotherapy may be of importance. Thus, the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR.
Interventions
- Other fall prevention programe
Patients in the experimental group will receive a comprehensive fall prevention program (guided by the post-TKR protocol followed at Al-Razi Orthopedic Hospital) into the conventional physiotherapy treatment
Primary outcome measures
- falls rate [Time frame: baseline]
- falls rate [Time frame: 12 weeks]
- falls rate [Time frame: 1 year]
Secondary outcome measures (6)
- Knee range of motion (ROM) [Time frame: baseline]
- Knee range of motion (ROM) [Time frame: 12 weeks]
- Patient's satisfaction [Time frame: 12 weeks]
- Patient's satisfaction [Time frame: 1 year]
- Adherence: [Time frame: 12 weeks]
- Adherence: [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Female gender.
- Aged 60 years and older.
- Diagnosed with primary osteoarthritis of the knee.
- Underwent unilateral TKR.
Exclusion criteria
- revision TKR surgery
- history of systemic inflammatory conditions (i.e., rheumatoid arthritis, Lupus erythematosus),
- neurological disorders (i.e., multiple sclerosis, Parkinson's disease, stroke)
- lower limb surgery/trauma in the past 12 months
- have cognitive and/or vision impairments
- post-surgical complications (e.g., infection, intraoperative fracture)
- any health condition that may preclude them from undertaking physiotherapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Kuwait · 1 center
- Alrazi orthopedic hospital — Kuwait City
Publications
- Al-Saleh H, Merza E, Al-Adwanie B, Pearson S, Malliaras P. The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol. Contemp Clin Trials. 2025 Mar;150:107837. doi: 10.1016/j.cct.2025.107837. Epub 2025 Feb 6. PMID 39921156
Identifiers
NCT: NCT05642260 · 2146/2022