Training of Patients With Hip Fracture

NCT01174589 | Completed Phase 2

• 1 other identifier: SJ-145
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to illustrate whether there is a difference in the 6 minutes walking test in patients with hip fractures who have received 6 vs. 12 weeks of physical training after discharge from hospital.

Conditions

Hip Fracture

Keywords

Lower limb strength training; Randomized clinical trial; Patients with Hip fracture; 6 vs. 12 weeks physical strength training

Outcome Measures

Primary Outcomes (1)

• Difference in the 6-minutes walking test

  The 6-minutes walking test, performed according to international guidelines.

  at baseline, 6 weeks, 12 weeks (primary analysis) and 24 weeks after baseline testing

Secondary Outcomes (5)

• Difference of the Maximal isometric knee-extension strength of the fractured limb.

  Baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

• Difference in 10-meter fast speed walking test

  At baseline, 6 weeks, 12 weeks, and 24 weeks after baseline testing

• Difference in the Timed Up & Go test

  At baseline and 6 weeks, 12 weeks and 24 weeks after baseline testing

• Difference in the Short Form-36

  At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

• Difference in the New Mobility Score

  At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

Other Outcomes (2)

• Difference in the Barthel 0-20 points ADL-score

  At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

• The Tandem Balance test 0-30 points

  At baseline, 6 weeks, 12 weeks and 24 weeks after baseline testing

Study Arms (2)

6 weeks of physical training

OTHER

The 6 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.

Other: Strength training

12 weeks of physical exercise

OTHER

The 12 weeks of physical training consists of muscle strength training of both legs, balance and coordination exercises 2 times a week.

Other: Strength training

Interventions

Strength training OTHER

to compare if there is a difference between 6 or 12 weeks of physical strength training

12 weeks of physical exercise; 6 weeks of physical training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with hip fractures
• full weightbearing on the affected leg
• patients living in their own home with an independent walking ability score \>=2 according to the New Mobility Score scale
• written consent

You may not qualify if:

• institutionalized patients
• more than 2 weeks after discharge from hospital
• non weight bearing on the affected leg
• Dementia
• other conditions/diagnosis that would have an effect on the ability to train eg. neurological diagnosis

Sponsors & Collaborators

• Lolland Community, Denmark: lead
• Association of Danish Physiotherapists: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (1)

Maribo Health Center

Maribo, 4930, Denmark

Location

Related Publications (2)

• 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

• Overgaard JA, Kallemose T, Mangione KK, Kristensen MT. Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1455-1462. doi: 10.1093/gerona/glab256.

  PMID: 34460897 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jan Overgaard, MSc.

  Sector of health, rehabilitation, Lolland community, Denmark

  PRINCIPAL INVESTIGATOR

• Morten T Kristensen, PhD

  Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Bachelor, Sector of Health, Rehabilitation, Lolland Community.

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: August 3, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

DK (1)