NCT03747289

Brief Summary

The effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. Therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain. 40 women with osteoporosis and low back pain will be divided into two groups. Each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. The participants will be tested before starting the program, immediately after finishing it and again two months later. The tests will include filling out the Roland Morris Disability Questionnaire, the SF-36 quality of life Questionnaire, pain measurement by VAS (Visual Analogue Scale) and lumbar range of motion measurement by a digital Inclinometer. Statistical analysis will be made in order to compare the dependent variables between groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

August 17, 2021

Status Verified

January 1, 2021

Enrollment Period

2.2 years

First QC Date

August 1, 2018

Last Update Submit

August 15, 2021

Conditions

OsteoporosisLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change of physical disability

    the Roland Morris Disability Questionnaire. The score of the questionnaire is the total number of items checked - i.e. from a minimum of 0 to a maximum of 24.

    3 months

Secondary Outcomes (3)

  • change in lumbar range of motion - flexion and extension

    3 months

  • change in pain intensity

    3 months

  • change in health related quality of life

    3 months

Study Arms (2)

weight bearing group

EXPERIMENTAL

performing exercises in a weight bearing posture

Other: performing exercises in a weight bearing posture

non-weight bearing group

ACTIVE COMPARATOR

performing exercises in a non- weight bearing posture

Other: performing exercises in a non weight bearing posture

Interventions

performing exercises in a weight bearing postureOTHER

20 participants will perform exercises in a weight bearing posture

weight bearing group
performing exercises in a non weight bearing postureOTHER

20 participants will perform exercises in a non weight bearing posture

non-weight bearing group

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with osteoporosis (T score lower than -2.5)
  • women whom had suffered from non specific low back pain for the last 3 months or more.

You may not qualify if:

  • history of operations in the spine
  • history of cancer or neurologic disease
  • history of fractures
  • previous trauma to the spine
  • persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi health services

Bat Yam, Israel

Location

MeSH Terms

Conditions

OsteoporosisLow Back Pain

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
the investigator will check all the participants without knowing to which group they are assigned to
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

November 20, 2018

Study Start

December 20, 2018

Primary Completion

February 22, 2021

Study Completion

February 22, 2021

Last Updated

August 17, 2021

Record last verified: 2021-01

Locations

IL(1)