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

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ClinicalTrials.gov Identifier: NCT02407444
Recruitment Status : Unknown
Verified March 2016 by AVITAL HERSHKOVITZ, Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : April 3, 2015
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
Beit-Rivka Geriatric Rehabilitation Hospital
Information provided by (Responsible Party):
AVITAL HERSHKOVITZ, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Other: Physiotherapy treatment & leg cycling Other: Physiotherapy treatment & music listening Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physiotherapy treatment & leg cycling

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

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.


Active Comparator: Physiotherapy treatment & music listening

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

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 Measures :
  1. FIM ( functional independence measure) [ Time Frame: baseline-at the first day of intervention ]
    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.

  2. Static balance test and weight bearing distribution while standing [ Time Frame: baseline-at the first day of intervention ]
    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.

  3. Muscle strength [ Time Frame: baseline-at the first day of intervention ]
    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.

  4. Pain intensity (measured with VAS) [ Time Frame: baseline-at the first day of intervention ]
    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.

  5. Change from baseline in FIM at 2 weeks [ Time Frame: Second week of intervention ]
    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.

  6. Change from baseline in FIM at 3 weeks [ Time Frame: End of intervention at third week ]
    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.

  7. Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks [ Time Frame: Second week of intervention ]
    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.

  8. Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks [ Time Frame: End of intervention at third week ]
    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.

  9. Change from baseline in muscle strength at 2 weeks [ Time Frame: Second week of intervention ]
    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.

  10. Change from baseline in muscle strength at 3 weeks [ Time Frame: End of intervention at third week ]
    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.

  11. Change from baseline in pain intensity at 2 weeks (measured with VAS) [ Time Frame: Second week of intervention ]
    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.

  12. Change from baseline in pain intensity at 3 weeks (measured with VAS) [ Time Frame: End of intervention at third week ]
    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.



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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407444


Contacts
Contact: Avital Hershkovitz, MD-PhD +972522342123 avitalhe@clalit.org.il
Contact: Hila Dahan, BPT +972542458459 dahan.hila@gmail.com

Locations
Israel
"Beit- Rivka" geriatric rehabilitation hospital Recruiting
Petach tiqva, Israel
Contact: Avital Hershkovitz, MD-PhD    +97239373841    avitalhe@clalit.org.il   
Contact: Hila Dahan, BPT    +97239373839    dahan.hila@gmail.com   
Sponsors and Collaborators
Rabin Medical Center
Beit-Rivka Geriatric Rehabilitation Hospital
Investigators
Principal Investigator: Avital Hershkovitz, MD-PhD Beit-Rivka Geriatric Rehabilitation Hospital
Study Chair: Youssef Ma Masharawi, PhD Tel Aviv University

Responsible Party: AVITAL HERSHKOVITZ, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02407444     History of Changes
Other Study ID Numbers: rmc150495ctil
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

Keywords provided by AVITAL HERSHKOVITZ, Rabin Medical Center:
Proximal hip fracture
Elderly patients
Physiotherapy
Leg cycling ergometer

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries