Please select the eligibility criteria that correspond to the clinical trial below.
Title: Build Better Bones With Exercise: A Pilot Randomized Controlled Trial of Exercise in Women With Osteoporotic Vertebral Fracture
Brief Summary: The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.


Options:
A: Inclusion Criteria

* Woman aged ≥ 60 years
* Osteoporosis according to DXA (Dual X-Ray Absorptiometry) hip (femoral neck or total hip) or lumbar spine.
* Back pain.

Exclusion Criteria

* Diagnosed symptomatic spinal stenosis
* Difficulty to participate in the activities included in the study due to health problems.
* Difficulty to participate in equipment training group.
* Inability to be able to complete wearing the spinal orthosis.
* Language difficulties
* Cognitive difficulties
* Visual problems
B: Inclusion Criteria:

* Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:

  * documented height loss of ≥2cm
  * historical height loss of ≥6cm
  * visible hyperkyphosis
* age greater than or equal to 65 years of age
* able to understand instructions in english
* able to give informed consent (no cognitive impairment)

Exclusion Criteria:

* Current or prior cancer
* On dialysis, known liver, kidney or malabsorption disease
* Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
* Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
* Uncontrolled hypertension or other contraindications to exercise
C: Inclusion Criteria:

Primary inclusion criteria for receiving MRI

* The patient must have LBP with a current duration of 3 - 12 month.
* The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.

Secondary inclusion criteria for receiving MRI

* The patient must speak and understand Danish.
* The patient must be between 18-60 years of age.
* The patient must be willing to participate in the project. Inclusions criterium for the project
* There must be an MRI showing MC in the lumbar spine.

Exclusion Criteria:

* The patient is unable to go through with the project because of other physical or mental disorder.
* The patient is pregnant.
* The patient is referred to operation.
D: Inclusion Criteria:

1. age 70 to 89 years; (2) summary score \<10 on the short physical performance battery (SPPB) (45% are \<8);90 (3) sedentary lifestyle; (4) ability to complete the 400 m walk test without an assistive device; and (5) willingness to be randomized to either intervention group.

   Exclusion Criteria:

   Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial • Unable or unwilling to give informed consent or accept randomization in either study group • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
   * Current consumption of more than 14 alcoholic drinks per week
   * Plans to relocate to out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year
   * Self-reported inability to walk across a small room
   * The use of a walker to complete the 400 m walk and/or unable to complete the 400 m walk without sitting down or the help of another person
   * Another member of the household is a participant in the Life Study
   * Residence too far from the intervention site
   * Residence in a nursing home
   * Difficulty in communication with study personnel due to speech or hearing problems
   * Modified Mini-Mental State Exam (3MSE) score below the cutoff for education:

   African American, 9+ yrs 76, \<9 yrs 70; English Speaking Non-African American, 9+ yrs 80, \<9 yrs 76; Spanish Speaking, 9+ yrs 80, \<9 yrs 70
   * Participation in LIFE-Pilot study
   * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

   Exclusion Criteria for Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions

   • Severe arthritis (either osteoarthritis or rheumatoid arthritis)

   • Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)

   • Lung disease requiring either regular use of corticosteroid pills or injections or the use of supplemental oxygen

   • Development of chest pain or severe shortness of breath on a 400 m self-paced walk test

   • Cardiovascular disease (including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history or cardiac arrest, use of a cardiac defibrillator or uncontrolled angina)

   • Parkinson's disease or other serious neurological disorder

   • Renal disease requiring dialysis

   • Other illness of such severity that life expectancy is considered to be less than 12 months

   • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site

   Temporary Exclusion Criteria

   • Uncontrolled hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg).

   • Uncontrolled diabetes with recent weight loss, diabetic coma or frequent insulin reactions.
   * Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months.
   * Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (\>3 mm) on ECG.
   * Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months.
   * Undergoing physical therapy or cardiopulmonary rehabilitation
   * Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions

Answer: B