Active Rehabilitation in Osteoporotic Patients

NCT01357278 | Completed

• 1 other identifier: OsteoActive
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to target risk factors for falling, such as improved quadriceps muscle strength,balance and bone mineral density (BMD), to reduce the risk of osteoporotic fractures. Furthermore, to improve quality of life for patients with osteoporosis through an active rehabilitation program. Sub-goals:

1. 1.To assess the effect of active rehabilitation on risk factors for osteoporotic fractures (muscle strength, bone mineral density, balance and frequency of falling) in women with low bone mineral density (BMD)(t-score\<1.5) and radius fracture?
2. 2.To assess how active rehabilitation affect the quality of life of women with low bone mineral density(BMD) (t-score\<1.5) and radius fracture?

Conditions

Osteoporosis

Keywords

osteoporosis; exercise; intervention; rehabilitation; bone mineral density; muscle strength

Outcome Measures

Primary Outcomes (3)

• Quadriceps Muscle Strength

  Quadriceps muscle strength will be examined using isokinetic muscular strength tests on a Biodex machine (Biodex System 3 Pro, USA) and measured as peak torque (N-M) and total work of 60 and 180 degrees per second.

  Baseline

• Quadriceps Muscle Strength

  Quadriceps muscle strength will be examined using isokinetic muscular strength tests on a Biodex machine (Biodex System 3 Pro, USA) and measured as peak torque (N-M) and total work of 60 and 180 degrees per second.

  6 months

• Quadriceps Muscle Strength

  Quadriceps muscle strength will be examined using isokinetic muscular strength tests on a Biodex machine (Biodex System 3 Pro, USA) and measured as peak torque (N-M) and total work of 60 and 180 degrees per second.

  12 months

Secondary Outcomes (18)

• Bone Mineral Density

  Baseline

• Dynamic balance

  Baseline

• The quality of life

  Baseline

• Physical function/walking capacity

  Baseline

• Physical activity level

  Baseline

Study Arms (2)

Rehabilitation and patient education

EXPERIMENTAL

Supervised rehabilitation consists of exercises for strength, balance and coordination twice weekly, and a home-training programme once weekly. Patient education will be offered every eight week.

Procedure: Rehabilitation and patient education

Patient education

NO INTERVENTION

Patient education will be offered every eight week.

Interventions

Rehabilitation and patient education PROCEDURE

Supervised rehabilitation consists of exercises for strength, balance and coordination twice weekly, and a home-training programme once weekly. Patient education will be offered every eight week.

Also known as: OsteoActive and OsteoInfo

Rehabilitation and patient education

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven low bone mineral density (t-score \< 1.5) plus radius fracture
• The radius fracture must not be older than 2 years, and must be healed by start of intervention (no plaster cast)
• Postmenopausal women above 50 years
• Domicile in the Oslo region

You may not qualify if:

• Hip fracture or vertebral fracture
• History of more than 3 osteoporotic fractures in different parts of the body
• Problems/illnesses indicating that active rehabilitation is not indicated
• Physical activity (moderate and hard intensity) for more than 4 hours a week
• Does not understand Norwegian, written and spoken

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian School of Sport Sciences: collaborator

Study Sites (1)

NAR, Department of Orthopaedics, Oslo University Hospital

Oslo, 0407, Norway

Location

Related Publications (2)

• Hakestad KA, Torstveit MK, Nordsletten L, Risberg MA. Effect of exercises with weight vests and a patient education programme for women with osteopenia and a healed wrist fracture: a randomized, controlled trial of the OsteoACTIVE programme. BMC Musculoskelet Disord. 2015 Nov 14;16:352. doi: 10.1186/s12891-015-0811-z.

  PMID: 26578370 DERIVED

• Hakestad KA, Torstveit MK, Nordsletten L, Axelsson AC, Risberg MA. Exercises including weight vests and a patient education program for women with osteopenia: a feasibility study of the OsteoACTIVE rehabilitation program. J Orthop Sports Phys Ther. 2015 Feb;45(2):97-105, C1-4. doi: 10.2519/jospt.2015.4842. Epub 2015 Jan 10.

  PMID: 25579693 DERIVED

MeSH Terms

Conditions

Osteoporosis; Motor Activity

Interventions

Rehabilitation; Patient Education as Topic

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Health Education; Preventive Health Services

Study Officials

• May Arna Risberg, dr philos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kari Anne Hakestad

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: May 20, 2011
• Study Start: January 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

NO (1)