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Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608749
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

BACKGROUND: The deterioration of musculoskeletal system imposes significant impact on physical activity in older adults.

METHODS: This was a randomized, parallel-group, prospective study. All participants received education program including home-based exercise. The IC group consisted of different modalities of exercise while the LEE group performed machine-based exercise. Body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.


Condition or disease Intervention/treatment Phase
Osteoporosis Fracture Behavioral: Integrated care (IC) Behavioral: Lower extremity exercise (LEE) Behavioral: Home care (HC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Osteoporosis and Fall Prevention High Risk Population Intervention and Follow up in the Metropolitan Area
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Osteoporosis

Arm Intervention/treatment
Experimental: IC
Integrated care (IC)
Behavioral: Integrated care (IC)
Integraded care (IC) Weekly professional led exercise program for 90 mins with reinforcemen on osteoporosis related educations and caremangements from study educational booklet and CD rom for 3-month. The exercise program included 15 minutes warm up with 10 minute brisk walks followed by gentle stretching. Resistance training (20-30 minutes) was provided with rubber band and bottled water (0.6-1L) as weight for major muscles of upper and lower limbs. Balance training were also provided for 10 minutes with tandem gaits and one leg standing, step up and down stairs, toe walking and heel walking.

Experimental: LEE
Lower extremity exercise (LEE)
Behavioral: Lower extremity exercise (LEE)
Lower extremity exercise (LEE) group subjects were invited to BB site to receive 2 sessions of 45-mintute training using isotonic strength training machines on major muslce groups each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments by trained physical therapist.

Experimental: HC
Home care (HC)
Behavioral: Home care (HC)
Home care (HC) group subjects were invited to LK site. For examining whether the exercise video could help elderly people to maintain their exercise and improve their muscle strength or not, the investigators provided exercise video to subjects, and encouraged them to play this exercise at least 2 hours for one week.




Primary Outcome Measures :
  1. Lower extremity extensor power measured by isokinetic resistance equipment [ Time Frame: 12 weeks ]
    Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. older than 50 years of age
  2. high risk as defined from one of the following criteria

    • score>=1 on one minute osteoporosis risk questionnaire
    • 10 year predicted fracture risk >=20% for major osteoporosis fracture or >=3% for hip fracture from FRAX
    • fall>=2 times in pass 1 year
  3. having a bone mineral density test within one year period
  4. having the capability to understand the study and complete the study interventions
  5. willing to participate for the intervention and study follow ups

Exclusion Criteria:

1. If patients were unable to meet at least the above inclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608749


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ding-Cheng Chan National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02608749    
Other Study ID Numbers: 201402022RINB
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015
Keywords provided by National Taiwan University Hospital:
Osteoporosis
Fall
Fracture
Sacopenia
Body Composition
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases