Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise.

NCT04469374 | Terminated

• 1 other identifier: StaffsUni1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: to examine the effect of an exercise intervention for preventing osteoporosis among postmenopausal women. Objectives: To examine whether mean values for Broadband Ultrasound Attenuation (BUA) using Quantitative Ultrasound (QUS) among postmenopausal women following an eight-month exercise intervention (and at 3-month follow up), will be significantly higher than those obtained pre-intervention. To examine whether mean BUA values among postmenopausal women following an eight-month exercise intervention (and at 3-month follow up) will be significantly higher than mean values obtained from participants in a control group undertaking sham exercises for an equivalent duration. To examine the feasibility of the eight-month exercise intervention for a potential larger study (larger sample size, increased number of trial arms and increased outcome measures), in terms of recruitment, adherence, perceptions, barriers, and acceptability.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Broadband ultrasound attenuation

  BUA as measured by Quantitative Ultrasound (UBIS 5000 Diagnostic Medical Systems, Montpellier, France).

  8 months

Secondary Outcomes (4)

• Timed up-and-go test

  8 months

• Ground reaction force

  8 months

• Jump height

  8 months

• Questionnaire on quality of life

  8 months

Study Arms (2)

Jumping exercise

EXPERIMENTAL

10 rest-inserted jumps performed three times per week

Other: Jumping exercise

Balance exercise

SHAM COMPARATOR

Single-leg balances for 60 seconds on each leg

Other: Balance exercise (sham control)

Interventions

Jumping exercise OTHER

Participants will be required to perform 10 maximal vertical jumps, with a 10-s rest interval between each jump, using an arm swing in countermovement style on three days per week. The jumps will be performed without shoes on a hard surface. The jumps will be preceded by a warm-up lasting approximately 3 min and consisting of mobilisation exercises for the legs and lower back. Jumping will be progressed over time and in accordance with individual needs.

Jumping exercise

Balance exercise (sham control) OTHER

Participants will be required to perform balance exercises. Participants will be required to balance on one leg for up to 60 seconds (2 x 60 s is equivalent in duration to the 10 jumps). This exercise will be progressed.

Balance exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal; aged ≥50 years

Sponsors & Collaborators

• Staffordshire University: lead

Study Sites (1)

Staffordshire University

Stoke, England, ST4 2DF, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Exercise Physiology

Model Details: The project will be a randomised controlled trial, investigating between and within group differences pre- and post-intervention. There will be two trial arms: an intervention group and sham control group.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: July 14, 2020
• Study Start: December 1, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)