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NCT05060380 | NOT YET RECRUITING | Osteopenia

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Harshvardhan Singh

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.

Condition or disease

Osteopenia

Osteoporosis

Postmenopausal Osteoporosis

Sarcopenia

Intervention/treatment

Exercise training

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 44 participants
Masking : SINGLE
Masking Description : Outcomes assessor will be blinded to the group assignment.
Primary Purpose : OTHER
Official Title : Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-06-01
Estimated Study Completion Date : 2026-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years to 70 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Location Details

NCT05060380

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How to Participate

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Locations

Not yet recruiting

United States, alabama

University of Alabama at Birmingham

Birmingham, alabama, United States, 35294