Clinical trial NCT05642260: Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fall
Osteo Arthritis Knee
Total Knee Replacement
Keywords: fall
older people
fall prevention
TKR
rehabilitation
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2022-12-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: falls rate
timeFrame: baseline
measure: falls rate
timeFrame: 12 weeks
measure: falls rate
timeFrame: 1 year
Secondary outcomes:
measure: Knee range of motion (ROM)
timeFrame: baseline
measure: Knee range of motion (ROM)
timeFrame: 12 weeks
measure: Patient's satisfaction
timeFrame: 12 weeks
measure: Patient's satisfaction
timeFrame: 1 year
measure: Adherence:
timeFrame: 12 weeks
measure: Adherence:
timeFrame: 1 year
Other outcomes:
measure: Numerical Pain Rating Scale NPRS
timeFrame: baseline, 12 weeks, 1 year
measure: 10-meter walk test
timeFrame: baseline, 12 weeks
measure: Timed Up and Go test
timeFrame: baseline, 12 weeks
measure: Berg Balance Scale (BBS)
timeFrame: baseline, 12 weeks
measure: 30 second sit to stand:
timeFrame: baseline, 12weeks
Locations:
city: Kuwait
country: Kuwait
facility: Alrazi orthopedic hospital
Study officials:
affiliation: Ministry of Health
name: Hadeel H Alsaleh, PhD
role: STUDY_DIRECTOR
References: