Identifying the link between bone and muscle in older-adults : effects of exercise

Not Applicable

Recruiting

• Conditions: ow muscle mass; osteoporosis; Sarcopenia; Low muscle mass; Musculoskeletal - Osteoporosis; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12618001756213
• Lead Sponsor: Victoria University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Males and females aged >60 years. Females in particular will be required to be a minimum of 12 months post menopause

Exclusion Criteria

-Any fractures in the previous 3 months, or are currently undergoing a new osteoporotic treatment within 3months or have begun taking anti-resorptive medications within 3months.
-have diabetes mellitus or are taking hyperglycaemic medications. This is because of the close interaction and effects of osteocalcin and glucose metabolism.
-any haematological, myelodysplastic or myoproliferative disorder
-any bone malignancy
-taking warfarin of vitamin K supplementation or restriction
-a Body mass index greater than 40kg/m2
-Engagement in resistance exercise regime more than 2 sessions per week.

Additional criteria include:
-are unable to give informed consent independently, we will not include any persons who are unable to give independent informed consent for safety reasons, particularly as we take some invasive measures.
-pregnancy, it is remains unclear the effects of maximal exercise whilst during pregnancy, as such for safety reasons we will not include pregnant women.
-unable to understand English, this could potentially be a safety concern if unable to communicate during some of the maximal exertion testing visits, and for the acute exercise bout.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall change in bone remodeling markers (osteocalcin, P1NP and b-CTx). These will be assessed in serum[Baseline and 0, 30, 60, 90 (primary endpoint) and 120 mins post exercise];Expression of proteins associated with muscle hypertrophy/degradation (exploration, including mTOR), as measured by Western Blots, in human myotubes following osteocalcin and other treatments on in vitro. [0, 30, 60, 120mins (primary endpoint) and 24hrs and 72hrs post treatment ];Muscle signaling proteins (exploratory). This will be assessed via muscle biopsies [Baseline and 1 h post exercise]

Secondary Outcome Measures

Name	Time	Method
Genetic analysis. Exploratory outcome[Baseline blood only be used for baseline correlation ];Vascular function, flow mediated dilatation (FMD), using ultrasound of the brachial artery.[Data will be collected at baseline only as it is specific for study 1.];Bone mineral density (DXA) [Baseline only, this is specific for Study 1.];Muscle strength, 1RM, will be assessed to characterise the participants[Assessment will be performed at baseline only as it is specific for Study 1.];Cell culture, in vitro, treatment with antiresorptive drugs. Proteins involved in muscle hypertrophy/degradation will be assessed. This is an exploratory outcome.[0, 30, 60, 120mins and 24hrs and 72hrs post treatment ];Blood analysis for cardiometabolic health markers. This is an exploratory outcome. [Baseline and 0, 30, 60, 90 and 120 mins post exercise];Bone structure including cortical and trabecular bone using pQCT.[Baseline only as it is specific for Study 1.]