Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

Osteo Arthritis Knee Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642260
• Other study ID #: 2146/2022
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2023
• Est. completion date: January 8, 2025

Study information

• Verified date: January 2024
• Source: Ministry of Health, Kuwait
• Contact: Hadeel H Alsaleh, PhD
• Phone: 0096565064141
• Email: golden_land85[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 8, 2025
• Est. primary completion date: September 8, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Replacement

Intervention

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

Locations

Country	Name	City	State
Kuwait	Alrazi orthopedic hospital	Kuwait

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Kuwait

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numerical Pain Rating Scale NPRS	The worst pain experienced in the last week will be measured using the Numerical Pain Rating Scale (NPRS). The NPRS requires the patients to rate their pain on a defined scale from 0-10 where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients will be asked "Regarding your knee pain, how would you rate the worst pain that you have experienced during the last week?". A numeric change of two points on NPRS often represents a clinically important difference.	baseline, 12 weeks, 24 weeks
Other	10-meter walk test	This test assesses walking speed in meters per second over a short distance. The subject walks without assistance for 10 meters (32.8 feet) and the time is measured for the intermediate 6 meters (19.7 feet) to allow for acceleration and deceleration.	baseline, 12 weeks, 24 weeks
Other	Timed Up and Go test	This test measures, in seconds, the time taken by an individual to stand up from a standard armchair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. The time taken to complete the task is strongly correlated to level of functional mobility, (i.e. the more time taken, the more dependent in activities of daily living).	baseline, 12 weeks, 24 weeks
Other	Berg Balance Scale (BBS)	Is a 14-item scale designed to measure balance of the older adult in a clinical setting. Each item consists of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. The total score equals 56. Score of < 45 indicates individuals may be at greater risk of falling (Berg et al., 1992).	baseline, 12 weeks, 24 weekss
Other	30 second sit to stand:	This test measures leg strength and endurance in older adults. The subject is encouraged to complete as many full stands as possible within 30 seconds without using their arms. The subject is instructed to fully sit between each stand. The score is the total number of stands within 30 seconds.	baseline, 12weeks 24 weeks
Primary	falls rate	The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).	baseline
Primary	falls rate	The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).	12 weeks
Primary	falls rate	The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).	24weeks
Primary	falls rate	The primary outcome measure in this trial will be the number of reported falls during the study period.The patients will be given a falls' diary to record the number of falls (if any), time of falling (e.g., early morning or late night), and the cause of falling (e.g., slippery floor, dizziness, tripping over).	1 year
Secondary	Knee range of motion (ROM)	This will be measured using goniometer while the patient is laying in supine position with the operated knee fully extended. The patient will be requested to bend her knee 2-3 times before the actual measurements are taken. Then, the investigator will take three consecutive measurements of knee flexion range.	baseline
Secondary	Knee range of motion (ROM)	This will be measured using goniometer while the patient is laying in supine position with the operated knee fully extended. The patient will be requested to bend her knee 2-3 times before the actual measurements are taken. Then, the investigator will take three consecutive measurements of knee flexion range.	12 weeks
Secondary	Knee range of motion (ROM)	This will be measured using goniometer while the patient is laying in supine position with the operated knee fully extended. The patient will be requested to bend her knee 2-3 times before the actual measurements are taken. Then, the investigator will take three consecutive measurements of knee flexion range.	24 weeks
Secondary	Patient's satisfaction	In response to the question 'how satisfied are you with the results of physiotherapy treatment?'. Patients will be asked to grade their level of satisfaction on a 5-point Likert scale (1: not at all satisfied, 2: dissatisfied, 3: neutral, 4: satisfied, or 5: very satisfied).	12 weeks
Secondary	Patient's satisfaction	In response to the question 'how satisfied are you with the results of physiotherapy treatment?'. Patients will be asked to grade their level of satisfaction on a 5-point Likert scale (1: not at all satisfied, 2: dissatisfied, 3: neutral, 4: satisfied, or 5: very satisfied).	24 weeks
Secondary	Adherence:	Adherence to the prescribed home-program: Patient's adherence to the prescribed exercise/home program will be measured by a retrospective patient self-report scale, a simple method that has been implemented by other researchers to measure patient's adherence to the prescribed exercise. (Mallows et al., 2020, Bassett, 2003) In response to the question "If you have been requested by your physiotherapist to do exercises at home, please indicates the extent you have followed the instructions?", participants responded using a 5-point Likert scale ranging from 1 (not at all) to 5 (as advised).; Adherence to physiotherapy attendance: The total number of treatment sessions received by the patient will be recorded by the treating physiotherapist.	12 weeks
Secondary	Adherence:	Adherence to the prescribed home-program: Patient's adherence to the prescribed exercise/home program will be measured by a retrospective patient self-report scale, a simple method that has been implemented by other researchers to measure patient's adherence to the prescribed exercise. (Mallows et al., 2020, Bassett, 2003) In response to the question "If you have been requested by your physiotherapist to do exercises at home, please indicates the extent you have followed the instructions?", participants responded using a 5-point Likert scale ranging from 1 (not at all) to 5 (as advised).; Adherence to physiotherapy attendance: The total number of treatment sessions received by the patient will be recorded by the treating physiotherapist.	24 weeks