Clinical trial NCT05060380: Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Official title: Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteopenia
Osteoporosis
Postmenopausal Osteoporosis
Sarcopenia
Keywords: aging
bone
muscle
exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals will be randomly assigned to exercise or no exercise group.
Primary purpose: OTHER

Brief summary: The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.

Detailed description: In 2008, medical cost of osteoporosis and osteoporosis-related fractures was estimated to be $22 billion. This is further expected to rise because of an increase of 20% in population with osteoporosis, amounting to 12 million adults over the age of 50 years, by 2020, out of which 80% will be postmenopausal women. Unfortunately, benefits due to pharmacological interventions have plateaued. Consequently, there is a critical need to identify complementary therapies to enhance the treatment of low bone mass in older adults. The aim of this study is to examine the feasibility of novel progressive muscle resistance exercise in postmenopausal women with low bone mass. Muscle will be assessed via imaging techniques and isokinetic dynamometer. Physical activity will be assessed via activity monitors. Blood will be collected to assess bone and muscle biomarkers. Balance will be assessed via clinical and biomechanical tests. Testing will be performed at 4 time points: baseline, 1 month, 3 month, and 6 months except imaging which will be done at the baseline and 6 months. The findings from this study will help us to understand the feasibility of resistive muscle exercise program in postmenopausal women with low bone mass.

Eligibility criteria: Inclusion Criteria:

* independent ambulatory
* diagnosed with low bone mass

Exclusion Criteria:

* uncontrolled hypertension
* secondary osteoporosis
* fragility fracture,
* clinical or laboratory evidence of hepatic
* renal disease,
* uncontrolled disorders of the parathyroid
* thyroid glands,
* a history of cancer in the past 5 years,
* any structured resistance training within the previous year, and
* past therapy with any drug for osteoporosis,
* any current therapy for osteoporosis except zoledronic acid,
* inability to walk independently or
* any other medical conditions which could restrict the potential participants from full participation as decided by their physician.

Primary outcomes:
measure: Bone biomarker
timeFrame: baseline
measure: Bone biomarker
timeFrame: 1 month
measure: Bone biomarker
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: HARSHVARDHAN SINGH, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: