Treatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture

Study Overview
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Brief Summary
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This study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation.

Detailed Description
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Adults who have experienced a fall, followed by proximal hip fracture that required surgery, suffer from specific problems that interrupt the rehabilitation period in their subacute phase. Various modes of treatment available as part of the physical rehabilitation but there is not enough data in the literature regarding the contribution of cycling training with leg cycle ergometer as part of conventional physiotherapy treatment in elderly patients after hip fracture surgery. This study evaluates whether the additional cycling to physiotherapy treatment will improve the functional ability, the balance performance while standing, hip muscle strength and pain level in those patients.

Official Title
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A Comparison of Two Physiotherapy Treatment Protocols, With and Without Cycling Training , in Elderly Patients With Hip Fractures at Their Subacute Stage Following Surgery

Conditions
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Hip Fractures

Intervention / Treatment
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* Other: Physiotherapy treatment & leg cycling
* Other: Physiotherapy treatment & music listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proximal hip fracture with full or partial weight bearing indication. Surgical fixation ( nailing or total hip replacement or hemiarthroplasty) Pre-morbid function: walking independently or under supervision with or without assistance aid Cognitive function: Mini-mental state examination score above 21 Exclusion Criteria: Pathological hip fracture. Unstable heart or pulmonary disease. Presence of other fractures as a result of the current fall. Neurological comorbidities ( CVA, Parkinson, MS ). Entering the rehabilitation center more than three weeks after hip surgery

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy treatment & leg cycling<br>This group will receive conventional physiotherapy treatments, each session will last 30 minutes. Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress. In addition this group will have cycling training with leg cycle ergometer for 20 minutes. This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. | Other: Physiotherapy treatment & leg cycling<br>* All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group. In addition each patient in this group will train with stationary leg cycle ergometer for 20 minutes under physical therapist's supervision . Cycling exercise intensity subjectively determined by the patient using RPE Borg scale . Maximal intensity level determined as 14 in Borg scale.<br>|
| Active Comparator: Physiotherapy treatment & music listening<br>This group will receive conventional physiotherapy treatments, each session will last 30 minutes .Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress. In addition this group will listen to music (while sitting on a chair) for 20 minutes.This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. | Other: Physiotherapy treatment & music listening<br>* All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group. In addition each patient in this group will listen to music with earphone for 20 minutes while sitting under physical therapist supervision. Overall treatment session will last 50 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIM ( functional independence measure) | Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function. | baseline-at the first day of intervention | 
| Static balance test and weight bearing distribution while standing | The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control. | baseline-at the first day of intervention | 
| Muscle strength | Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms. | baseline-at the first day of intervention | 
| Pain intensity (measured with VAS) | Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, 0 indicates no pain and 10 indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours. | baseline-at the first day of intervention | 
| Change from baseline in FIM at 2 weeks | Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function. | Second week of intervention | 
| Change from baseline in FIM at 3 weeks | Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function. | End of intervention at third week | 
| Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks | The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control. | Second week of intervention | 
| Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks | The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control. | End of intervention at third week | 
| Change from baseline in muscle strength at 2 weeks | Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms. | Second week of intervention | 
| Change from baseline in muscle strength at 3 weeks | Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms. | End of intervention at third week | 
| Change from baseline in pain intensity at 2 weeks (measured with VAS) | Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, 0 indicates no pain and 10 indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours. | Second week of intervention | 
| Change from baseline in pain intensity at 3 weeks (measured with VAS) | Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, 0 indicates no pain and 10 indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours. | End of intervention at third week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal hip fracture, Elderly patients, Physiotherapy, Leg cycling ergometer