Improving Community Ambulation After Hip Fracture

NCT01783704 | Completed DMC

• 2 other identifiers: HP-000469561R01AG035009-01A1
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief Summary

Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults do not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program. This study is being done to compare two 16-week supervised multi-part physical therapy programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want to test whether the interventions lead to improvements in a person's ability to walk on their own in the home and in the local community. With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health. ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture. Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland, Baltimore (UMB) clinical site of CAP. ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture. The identified dietary patterns, as well as motivators and barriers to intake, will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center (UCHC) clinical site of CAP. ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP. ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University (AU) clinical site of CAP.

Conditions

Hip Fracture

Keywords

hip fracture; randomized controlled trial; exercise

Outcome Measures

Primary Outcomes (1)

• Ability to walk 300 meters or more in six minutes

  The primary study outcome reflects the concept of a minimum distance a person needs to be able to walk to carry out usual activities in the community. This will be defined as achieving the threshold value of 300 meters or more on the Six-Minute Walk Test (SMWT). The SMWT is an assessment with excellent psychometric properties, and there is sound justification for a 300 m distance threshold on the SMWT (equivalent to walking at 0.8 m/s) to serve as an indicator for community ambulatory ability.

  16 weeks post-randomization

Secondary Outcomes (8)

• Ability to walk 300 meters or more in six minutes

  40 weeks post-randomization

• Endurance

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

• Balance

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

• Quadriceps muscle strength

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

• Lower extremity function

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

Other Outcomes (30)

• Activities of daily living (ADLs)

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

• Quality of life (SF-36)

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

• Balance confidence

  16 weeks post-randomization and 40 weeks post-randomization for a subset of participants

Study Arms (2)

PUSH and Nutrition

EXPERIMENTAL

PUSH is a specific multi-component intervention based on improving specific precursors to community ambulation. The intervention addresses endurance with continuous upright exercise for 20 min.; function by improving fast walking, standing from a chair, and stair negotiation; muscle performance by exercising to enhance lower extremity strength; and balance by performing unilateral activities and activities with decreased base of support. Participants receive 32 visits of approximately 60 minutes in duration from a study PT. Participants will receive up to three visits a week, on non-consecutive days, for 16 weeks. Visits take place in the participant's place of residence. Participants also receive the nutritional intervention for the duration of the 16-week study.

Dietary Supplement: Nutrition; Behavioral: PUSH

PULSE and Nutrition

EXPERIMENTAL

PULSE is a non-specific multi-component intervention in which participants will receive flexibility exercises, active range of motion (AROM) for the upper and lower extremities, breathing exercises, and transcutaneous electrical nerve stimulation (TENS). Participants receive 32 visits of approximately 60 minutes in duration from a study PT. Participants will receive up to three visits a week, on non-consecutive days, for 16 weeks. Visits will take place in the participant's place of residence. Participants will also receive the nutritional intervention for the duration of the 16-week study.

Dietary Supplement: Nutrition; Behavioral: PULSE

Interventions

Nutrition DIETARY_SUPPLEMENT

Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of randomization. Those who score ≤7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level \>3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level \>3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.

PULSE and Nutrition; PUSH and Nutrition

PUSH BEHAVIORAL

Strength components of the muscle performance intervention are performed using a portable progressive resistive exercise device (Shuttle® MiniPress, Contemporary Design Company, P.O. Box 5089, Glacier, Washington 98244). Muscle performance focuses on bilateral hip extensors, hip abductors, knee extensors, and plantar flexors. Balance and strength are addressed with additional exercises performed while standing. The endurance intervention begins with 2-3 minutes of continuous upper and lower extremity active range of motion (AROM) with the participant sitting in order to increase the participants' heart rate (HR) or exertion closer to the target zone. The participant is then asked to walk on level surfaces and/or up and down steps to keep the HR within the training zone for 20 minutes.

PUSH and Nutrition

PULSE BEHAVIORAL

During the AROM exercises, participants work to increase flexibility and range of motion. Exercises include the neck, shoulders, arms, trunk, hips, knees and ankles. During all AROM exercises, the participant focuses on deep breathing techniques. The second part of the session uses transcutaneous electrical nerve stimulation (TENS) on lower extremity muscle groups to decrease pain, thereby allowing greater ease of mobility. TENS uses low-level electrical current to stimulate superficial cutaneous nerve fibers through the skin. Flexible carbonized, disposable electrodes coated with a self-adhesive conductive polymer will be applied to the skin bilaterally near the motor points on muscle bellies (the gluteal complex, the quadriceps, and the gastrocnemius) for 7 minutes per muscle group.

PULSE and Nutrition

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Closed fracture of proximal femur
• Age 60 or older at time of randomization
• Minimal trauma fracture
• Non-pathologic fracture
• Surgical fixation of fracture
• Living in the community at time of fracture
• Ambulating without human assistance 2 months prior to fracture
• Unable to walk 300 m or more in 6 minutes without human assistance at time of randomization

You may not qualify if:

• Not English speaking
• Does not live within reasonable distance of the clinical center
• End stage renal disease on dialysis
• Recent myocardial infarction
• Uncompensated congestive heart failure
• Lower extremity amputation
• Symptoms of angina pectoris
• Chest pain or shortness of breath (including from severe COPD)
• Participant plans to move out of area or otherwise be unavailable during the 16-week intervention period
• Participation in another clinical trial
• Not community-residing (e.g., resident of a skilled nursing facility) at time of randomization
• Not fully weight-bearing on fractured leg or non-fractured leg at time of randomization
• Calculated creatinine clearance \< 15 ml/min
• Serum albumin \< 2.5 g/dl
• Hemoglobin \< 9 g/dl

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator
• Arcadia University: collaborator
• UConn Health: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (4)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Dartmouth Medical School

Lebanon, New Hampshire, 03756, United States

Location

Arcadia University

Glenside, Pennsylvania, 19038-3295, United States

Location

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MeSH Terms

Conditions

Hip Fractures; Motor Activity

Interventions

Nutritional Status; Pulse

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jay Magaziner, PhD, MSHyg

  University of Maryland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study PI (Magaziner) and Co-PI (Craik) and members of the Clinical Coordinating Center (Orwig, Lewis) are blinded to treatment assignment. Clinical site PIs and clinical site coordinators who are responsible for assigning work and/or assessing for treatment fidelity of PTs in both groups are unblinded. Staff who perform evaluations (clinical site visits and telephone interviews) after randomization and the Independent Safety Monitor (ISM) who will be blinded to treatment assignment. The PTs only know specific information about the intervention he/she is delivering. To minimize "contamination" of the interventions, each PT provides only one of the interventions and PTs do not have contact with participants in the other group or with PTs providing the intervention to the other group. As PTs are hired for the study, they are assigned at random to one of the interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: June 10, 2013
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)