Evaluation of analysis for validation of efficiency of practical exercise modalities in elderly men at risk for osteoporosis

Not Applicable

Completed

• Conditions: M81.9; M62.5; Osteoporosis, unspecified; Muscle wasting and atrophy, not elsewhere classified

• Registration Number: DRKS00013262
• Lead Sponsor: Klinische Studieneinheit, Orthopädische Klinik, Universität Würzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study Completion: 2021-01-01
• Results First Posted: 2021-06-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 47

Inclusion Criteria

Men aged = 65 years with at least one of the following critieria indicating osteoporosis

• reduced Bone Mineral Density (DXA) T-Score < - 2,5 (Hip or Lumbar Spine)
• previsously confirmed diagnosis of osteoporosis
• ongoing specific treatment of for osteoporosis
• anticipated 10-year fracture-risk >20% according to current DVO-Guidelines

Exclusion Criteria

• Presence of Total Hip / Knee / Ankle joint replacement
• Pacemaker / AICD
• Diagnosis of epilepsy
• acute thrombosis (<3 months)
• acute vertebral disc herniation (<3 months)
• Rheumatoid Arthritis
• gallstones
• stone anywhere in the urinary tract
• Open hernias
• Surgery within the last 3 months
• acute head injury
• current infection
• current fractures (< 3 months )
• any condition that would put the participant at an unacceptably high risik in case of participation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isometric trunc muscle strength measured by dynamography at baseline and after 6 months of exercise <br>(exploratory endpoint; no confirmatory approach)<br><br>

Secondary Outcome Measures

Name	Time	Method
Changes in the following parameters <br><br>• Short Physikal Performance Battery • Grip Strength (Handheld-Dynamometry)<br>before as well as 3 and 6 months after initiation of exericse intervention, respectively<br><br>• Body Sway (Balance X) • Jumping mechanography (Leonardo) • Bioimpedance Analysis (Akern) • Gait Analyiss (GAITRite) • Body composition (DXA, Bone mineral density, Bone mass, Fat mass, Fat-free body mass) • Muscel volume and constitution, paravertebral muscels lumbar spine (MRT) • Spirometry<br>before and 6 months after initiation of exericse intervention, respectively