Back to resultsTreatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture
Primary Purpose
Hip Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physiotherapy treatment & leg cycling
Physiotherapy treatment & music listening
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Proximal hip fracture, Elderly patients, Physiotherapy, Leg cycling ergometer
Eligibility Criteria
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
Sites / Locations
- "Beit- Rivka" geriatric rehabilitation hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physiotherapy treatment & leg cycling
Physiotherapy treatment & music listening
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02407444
First Posted
March 19, 2015
Last Updated
March 19, 2016
Sponsor
Rabin Medical Center
Collaborators
Beit-Rivka Geriatric Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02407444
Brief Title
Treatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture
Official Title
A Comparison of Two Physiotherapy Treatment Protocols, With and Without Cycling Training , in Elderly Patients With Hip Fractures at Their Subacute Stage Following Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
Collaborators
Beit-Rivka Geriatric Rehabilitation Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Proximal hip fracture, Elderly patients, Physiotherapy, Leg cycling ergometer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy treatment & leg cycling
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy treatment & music listening
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy treatment & leg cycling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy treatment & music listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
FIM ( functional independence measure)
Description
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.
Time Frame
baseline-at the first day of intervention
Title
Static balance test and weight bearing distribution while standing
Description
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.
Time Frame
baseline-at the first day of intervention
Title
Muscle strength
Description
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.
Time Frame
baseline-at the first day of intervention
Title
Pain intensity (measured with VAS)
Description
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.
Time Frame
baseline-at the first day of intervention
Title
Change from baseline in FIM at 2 weeks
Description
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.
Time Frame
Second week of intervention
Title
Change from baseline in FIM at 3 weeks
Description
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.
Time Frame
End of intervention at third week
Title
Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks
Description
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.
Time Frame
Second week of intervention
Title
Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks
Description
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.
Time Frame
End of intervention at third week
Title
Change from baseline in muscle strength at 2 weeks
Description
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.
Time Frame
Second week of intervention
Title
Change from baseline in muscle strength at 3 weeks
Description
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.
Time Frame
End of intervention at third week
Title
Change from baseline in pain intensity at 2 weeks (measured with VAS)
Description
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.
Time Frame
Second week of intervention
Title
Change from baseline in pain intensity at 3 weeks (measured with VAS)
Description
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.
Time Frame
End of intervention at third week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avital Hershkovitz, MD-PhD
Phone
+972522342123
Email
avitalhe@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Dahan, BPT
Phone
+972542458459
Email
dahan.hila@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avital Hershkovitz, MD-PhD
Organizational Affiliation
Beit-Rivka Geriatric Rehabilitation Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youssef Ma Masharawi, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Study Chair
Facility Information:
Facility Name
"Beit- Rivka" geriatric rehabilitation hospital
City
Petach tiqva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avital Hershkovitz, MD-PhD
Phone
+97239373841
Email
avitalhe@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Hila Dahan, BPT
Phone
+97239373839
Email
dahan.hila@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
36070134
Citation
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Results Reference
derived
Learn more about this trial
Treatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture
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