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

Hip Fractures Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02407444
• Other study ID #: rmc150495ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: March 19, 2015
• Last updated: April 2, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Rabin Medical Center
• Contact: Avital Hershkovitz, MD-PhD
• Phone: +972522342123
• Email: avitalhe[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	"Beit- Rivka" geriatric rehabilitation hospital	Petach tiqva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Beit-Rivka Geriatric Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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
Primary	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	No
Primary	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	No
Primary	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	No