Clinical trial NCT02407444: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: Proximal hip fracture
Elderly patients
Physiotherapy
Leg cycling ergometer
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Beit-Rivka Geriatric Rehabilitation Hospital
First posted: 2015-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: FIM ( functional independence measure)
timeFrame: baseline-at the first day of intervention
measure: Static balance test and weight bearing distribution while standing
timeFrame: baseline-at the first day of intervention
measure: Muscle strength
timeFrame: baseline-at the first day of intervention
measure: Pain intensity (measured with VAS)
timeFrame: baseline-at the first day of intervention
measure: Change from baseline in FIM at 2 weeks
timeFrame: Second week of intervention
measure: Change from baseline in FIM at 3 weeks
timeFrame: End of intervention at third week
measure: Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks
timeFrame: Second week of intervention
measure: Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks
timeFrame: End of intervention at third week
measure: Change from baseline in muscle strength at 2 weeks
timeFrame: Second week of intervention
measure: Change from baseline in muscle strength at 3 weeks
timeFrame: End of intervention at third week
measure: Change from baseline in pain intensity at 2 weeks (measured with VAS)
timeFrame: Second week of intervention
measure: Change from baseline in pain intensity at 3 weeks (measured with VAS)
timeFrame: End of intervention at third week
Secondary outcomes:
Other outcomes:
Locations:
city: Petach tiqva
country: Israel
facility: "Beit- Rivka" geriatric rehabilitation hospital
Study officials:
affiliation: Beit-Rivka Geriatric Rehabilitation Hospital
name: Avital Hershkovitz, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Youssef Ma Masharawi, PhD
role: STUDY_CHAIR
References:
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.