Pre- and Post-Operative Exercise in Patients With Hip Fracture

NCT05389800 | Not Yet Recruiting

• 1 other identifier: 402/26-7-2021
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to determine the benefits of a pre-operative aerobic exercise program and an 8-week postoperative aerobic exercise program with a portable upper extremity cycle-ergometer in patients with hip fracture.

Conditions

Hip Fractures

Keywords

hip fracture; exercise therapy; surgical stress; haemostasis; basic mobility

Outcome Measures

Primary Outcomes (2)

• Cumulated Ambulation Score

  The Cumulated Ambulation Score (CAS) is a reliable and valid instrument for assessing patients' basic mobility (getting in and out of bed, sit-to-stand from a chair, and walking), in orthopaedic wards. The minimum value is 0 and maximum 3 per day. The total 3-day CAS has a better prognostic value than the 1-day CAS, and is based on the sum score of the first three post-operative days, with a minimum value being 0 and maximum 9, for the total 3-day CAS, with a higher score means better outcome.

  Total 3-day Cumulated Ambulation Score post-operatively.

• Six Minute Walk Test (6MWT)

  The 6MWT is a sub-maximal exercise test that is used to determine aerobic capacity and endurance.

  8 weeks post-operatively

Secondary Outcomes (20)

• Cumulated Ambulation Score

  4 weeks post-operatively

• Six Minute Walk Test (6MWT)

  4, 26 & 52 weeks post-operatively

• Timed-Up & Go

  4, 8, 26 & 52 weeks post-operatively

• Modified Harris Hip Score

  At admission (for pre-operative status) and 4, 8, 26 & 52 weeks post-operatively (for current status)

• Lower Extremity Functional Scale

  At admission (for pre-operative status) and 4, 8, 26 & 52 weeks post-operatively (for current status)

Study Arms (2)

Aerobic Exercise (Moderate-Intensity Interval Training)

EXPERIMENTAL

Preoperative program: 120 seconds of moderate intensity exercise (64-76% HRmax, 12-13 in rate of perceived exertion (RPE), based on ACSM) and 120 seconds of passive rest in a total of 4 cycles. The basic program will last about 14 minutes, plus 6 minutes for warm-up and recovery. The program will be performed twice a day. Postoperative program: 120 seconds of moderate intensity exercise (64-76% HRmax, 12-13 in RPE, based on ACSM) and 120 seconds of passive rest in a total of 8 cycles. The basic program will last about 30 minutes, plus 6 minutes for warm-up and recovery. The program will be performed 3 times a week for a total of 8 weeks.

Other: Upper Extremity Aerobic Exercise

Control

NO INTERVENTION

Preoperatively: mild intensity activities focusing on memory and attention performing with upper limb movements using the interactive platform Kinems. The program will last about 20 minutes. To ensure that the intensity of activities is mild, there will be a simultaneous recording of heart rate, while at the end of each session the RPE scale will be evaluated. Postoperatively: none

Interventions

Upper Extremity Aerobic Exercise OTHER

Using a cycle-ergometer (Monark 881E)

Aerobic Exercise (Moderate-Intensity Interval Training)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: 65 years old and older
• Unilateral proximal femoral fracture/hip fracture (intertrochanteric or neck fracture)
• Ambulatory patients before fracture (with or without aid assistance)
• Agreed to participate and signed consent form

You may not qualify if:

• Pathological fractures (under musculoskeletal oncology)
• Severe neuropsychiatric disorder (eg severe psychiatric disorder, dementia, etc.) to the extent that the researcher deems the patient incompetent or likely unable to remain compliant with the follow-up
• Unable to implement the exercise program due to underlying pathology or disability in the upper extremities
• More than one fracture
• Severe and / or unstable cardiovascular disease \[e.g. congenital heart disease, uncontrolled severe hypertension (systolic blood pressure ≥ 180 mmHg and / or diastolic blood pressure ≥ 120 mmHg), unstable angina\]
• Neurological or other conditions that significantly impair function and independence (eg stage 3-5 Parkinson's disease according to Hoehn and Yahr, advanced Multiple Sclerosis, severe arthritis of degenerative or rheumatic etiology)
• Severe metabolic bone disease (eg Paget's disease, renal bone disease, osteomalacia), excluding osteoporosis
• Active deadly aggressive disease (eg end-stage cancer with an estimated survival expectancy of less than 6 months)
• Unable to understand the consent document and / or protocol instructions
• Refusal to participate in the research

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

1st Department of Orthopaedic Surgery, Medical School, National and Kapodistrian University of Athens

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Panagiotis Koulouvaris, MD

  1st Department of Orthopaedic Surgery, National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagiotis Koulouvaris, MD

CONTACT

+30 6947124919; info@drkoulouvaris.gr

Apostolos Z Skouras, PT

CONTACT

+306977964803; askouras@randp.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor, 1st Department of Orthopaedic Surgery, National and Kapodistrian University of Athens

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: May 25, 2022
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)