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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608749
• Other study ID #: 201402022RINB
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: November 19, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Osteoporosis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity extensor power measured by isokinetic resistance equipment	Lower extremity extensor power is measured by isokinetic resistance equipment by a trained research assistant with standardized protocol	12 weeks	No