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

NCT ID: NCT02407444

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-12-31

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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Physiotherapy treatment & leg cycling

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Physiotherapy treatment & music listening

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beit-Rivka Geriatric Rehabilitation Hospital

UNKNOWN

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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AVITAL HERSHKOVITZ

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avital Hershkovitz, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Beit-Rivka Geriatric Rehabilitation Hospital

Youssef Ma Masharawi, PhD

Role: STUDY_CHAIR

Tel Aviv University

Locations

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"Beit- Rivka" geriatric rehabilitation hospital

Petach Tiqva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Avital Hershkovitz, MD-PhD

Role: CONTACT

+972522342123

Hila Dahan, BPT

Role: CONTACT

+972542458459

Facility Contacts

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Avital Hershkovitz, MD-PhD

Role: primary

+97239373841

Hila Dahan, BPT

Role: backup

+97239373839

References

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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.

Reference Type DERIVED
PMID: 36070134 (View on PubMed)

Other Identifiers

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rmc150495ctil

Identifier Type: -

Identifier Source: org_study_id

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