Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of a Post-Rehabilitation Exercise Intervention
Brief Summary: Background:

Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture.

Specific Aims:

We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether:

Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.

This study will also investigate the following secondary hypotheses:

1. Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
2. The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
3. At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.

Target population:

The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services.

Intervention:

We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community.

Design:

A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:

* T0: baseline, at the point of discharge from formal rehabilitation;
* T2: 6-month outcome assessment
* T3: 9-month follow-up

Outcomes:

The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored.


Options:
A: Inclusion Criteria:

* Have a primary diagnosis of hip fracture;
* Aged 60 years and above;
* Have functional limitation (i.e., as determined by limitation in at least one of 9 functional tasks listed in the SF-36 physical function scale, excluding vigorous activities);
* Have recently been discharged from rehabilitation services;
* Be able to understand and communicate in English;
* Be able to safely and independently stand with or without the aid of a mobility device, without needing any assistance or supervision from another person;
* Have received written clearance from their primary care physician documenting no contra-indications for participating in the study;
* Be able to provide written informed consent.

Exclusion Criteria:

* Have serious cognitive deficits (i.e., a Mini-Mental State Examination score of less than 20)85;
* Have severe depression (i.e., a score of 20 or greater on the Geriatric Depression Scale)86;
* Have a terminal illness with survival expected to be less than 1 year;
* Have significant pulmonary or cardiovascular contraindications or pre-existing conditions that preclude participating in an exercise program;
* Legally blind;
* Currently receiving rehabilitation therapy;
* Live outside of the study's catchment area in the Boston metropolitan area and eastern Massachusetts.
B: Inclusion Criteria:

1. Older men or women aged 65 years and older (with no upper age limit).
2. An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation.
3. Low energy fracture (defined as a fall from standing height).
4. No other major trauma.
5. Admission to the rehabilitation clinic from 8 to 12 days after the surgery
6. Patients autonomous prior to fracture.
7. Provision of informed consent by patient.

Exclusion Criteria:

1. Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip) or upper extremity (i.e., radius, ulna or humerus fracture).
2. Orthopedic contraindications to mobilization and to lower extremity operated load;
3. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
4. Patients with neurological diseases.
5. Patients with important cardiac diseases.
6. Patients with a pathologic fracture.
7. Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification).
8. Patients with a previous history of frank dementia.
9. Terminally-ill (life expectation \< 6 months).
10. Patients who lived in an institution before the fracture event or were not self-sufficient.
C: Inclusion Criteria:

* Age 65 years or older
* Acute hip fracture admitted to one hospital center

Exclusion Criteria:

* A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
* Primary hyperparathyroidism
* Current cancer with wasting or bone metastases
* Hyperparathyroidism
* Sarcoidosis
* A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)
* Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
* non-surgical treatment
* no German language skills
* severe hearing or visual impairment
D: Inclusion Criteria:

* Patient has had surgery for a unilateral hip fracture, and is considered to be partially or fully weight bearing after the surgery
* Surgical repair of the fracture has occurred no more than 4 days post hip fracture
* Prior to starting the study medication, the patient is enrolled in a rehabilitation program (as an in-patient or as an out-patient)
* Patient is judged to have been able to ambulate independently at home prior to their hip fracture (able to walk indoors in a familiar setting with little or no aid from another person)

Exclusion Criteria:

* Patient has an unstable medical condition
* Patient has a hip fracture that is due to bone pathology other than osteoporosis (e.g., malignancy, or Paget's Disease), or major trauma (e.g. motor vehicle accident).
* Patient has Type I diabetes
* Patient has Type II diabetes with any of conditions;

  1. Patient is currently taking more than one anti-hyperglycemic agent, or is taking a single combination anti-hyperglycemic drug containing more than one anti-hyperglycemic medication
  2. Patient is currently receiving insulin. Note: A short-term course of insulin required for glycemic control post hip fracture surgery is not exclusionary
  3. Patient has diabetic retinopathy
  4. Patient is unwilling or unable to monitor glucose at home
* Patient has been diagnosed with any neuromuscular or neurological disease causing muscle weakness
* Patient has cancer, or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated in situ cervical cancer
* Patient has active carpal tunnel syndrome
* Patient was living in a nursing home prior to the hip fracture (Note: - Patients who were living in an assisted-living facility prior to the hip fracture are eligible for enrollment)
* Patient was permanently wheelchair bound prior to the hip fracture

Answer: A