Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

NCT04025866 | Completed DMC

• 1 other identifier: 2264 CE
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.

Conditions

Intertrochanteric Fractures

Keywords

conventional rehabilitation; arm ergometer; aerobic exercise; intertrochanteric fractures

Outcome Measures

Primary Outcomes (1)

• Analysis of feasibility

  To assess the feasibility, it will be evaluated: 1. The eligibility rate (the total number of patients admitted with femur fractures and screening divided by the total number of patients meeting the criteria). 2. The recruitment rate (the number of patients recruited among those eligible). 3. The subjects' compliance level will be analyzed dichotomously (no compliance \<10 sessions, yes compliance ≥ 10 sessions). 4. Rate of patients who lost the evaluation at the end of the treatment and at the follow-up after 100 days. 5. Any negative effects will be recorded and counted. The following types of adverse events will be calculated separately: a) adverse reactions, adverse events, serious adverse events and suspected serious adverse events. 6. Adherence to treatment: the number of sessions in which patients have reached goal 1) of 30 minutes and 2) intensity between 50%-85% HRmax.

  Up to 4 weeks

Secondary Outcomes (6)

• Timed Up and Go (TUG) test

  Up to 4 weeks

• 10-meter Walking Test (10mWT)

  Up to 4 weeks

• Cumulated Ambulation Score - Italian version (CAS-I)

  Up to 4 weeks

• Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels)

  Up to 4 weeks

• Maximum isometric force of the knee extensors

  Up to 4 weeks

Study Arms (2)

Conventional rehabilitation

ACTIVE COMPARATOR

Conventional rehabilitation treatment for inpatients with femur fracture

Other: Conventional rehabilitation

Aerobic exercise

ACTIVE COMPARATOR

Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture

Other: Conventional rehabilitation; Other: Aerobic exercise

Interventions

Conventional rehabilitation OTHER

1h/day for 5 days/week of conventional rehabilitation for femur fracture

Aerobic exercise; Conventional rehabilitation

Aerobic exercise OTHER

30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture

Aerobic exercise

Eligibility Criteria

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

You may qualify if:

• Older men or women aged 65 years and older (with no upper age limit).
• An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
• Low energy fracture (defined as a fall from standing height).
• No other major trauma.
• Admission to the rehabilitation clinic from 8 to 12 days after the surgery
• Patients autonomous prior to fracture.
• Provision of informed consent by patient.

You may not qualify if:

• Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip) or upper extremity (i.e., radius, ulna or humerus fracture).
• Orthopedic contraindications to mobilization and to lower extremity operated load;
• Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
• Patients with neurological diseases.
• Patients with important cardiac diseases.
• Patients with a pathologic fracture.
• Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification).
• Patients with a previous history of frank dementia.
• Terminally-ill (life expectation \< 6 months).
• Patients who lived in an institution before the fracture event or were not self-sufficient.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Veruno, Novara, 28010, Italy

Location

Related Publications (21)

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• Corna S, Arcolin I, Giardini M, Bellotti L, Godi M. Addition of aerobic training to conventional rehabilitation after hip fracture: a randomized, controlled, pilot feasibility study. Clin Rehabil. 2021 Apr;35(4):568-577. doi: 10.1177/0269215520968694. Epub 2020 Nov 1.

  PMID: 33131328 RESULT

• 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.

  PMID: 36070134 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefano Corna, MD

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: February 13, 2019
• Primary Completion: October 28, 2021
• Study Completion: January 11, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)