Trial record 2 of 14 for:    Open Studies | "Kyphosis"

Specialized Centers of Research (SCOR)on Sex Differences - Kyphosis Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01766674
First received: January 9, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

This is a randomized, controlled trial among 100 total males and females with hyperkyphosis, aged 60 years and older, to determine the effects of an exercise intervention that includes high intensity spinal muscle strengthening exercises compared to a usual care waitlist group.


Condition Intervention
Kyphosis
Behavioral: Kyphosis spinal strengthening exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Specialized Centers of Research (SCOR) Kyphosis Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Effect of exercise intervention on kyphosis [ Time Frame: 3-month post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in Cobb angle on lateral spine radiograph.


Secondary Outcome Measures:
  • Effect of exercise intervention on physical function [ Time Frame: 3-month post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in physical function with Modified Physical Performance Test (PPT), gait speed, Timed Up and Go, Timed Loaded Standing, 6 minute walk and spinal extensor muscle strength


Other Outcome Measures:
  • Effect of exercise intervention on health related quality of life (HRQOL) [ Time Frame: 3-month post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health Questionnaires.

  • Effect of exercise intervention on kyphosis [ Time Frame: 6month post baseline for crossovers ] [ Designated as safety issue: No ]
    Investigators will measure change in Cobb angle on lateral spine radiograph

  • Effect of exercise intervention on physical function [ Time Frame: 6month post baseline for crossovers ] [ Designated as safety issue: No ]
    Investigators will measure change in physical function with Modified Physical Performance Test (PPT), gait speed, Timed Up and Go, Timed Loaded Standing, 6 minute walk and spinal extensor muscle strength

  • Effect of exercise intervention on health related quality of life (HRQOL) [ Time Frame: 6month post baseline for crossovers ] [ Designated as safety issue: No ]
    Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health Questionnaires.

  • Difference in baseline characteristics and intervention effects in kyphosis in men and women [ Time Frame: 3month post baseline ] [ Designated as safety issue: No ]
    Investigators will compare the changes in kyphosis measurements, physical function, and HRQOL in response to the intervention exercises between men and women.

  • Difference in baseline characteristics and intervention effects in kyphosis in men and women [ Time Frame: 6month post baseline for crossovers ] [ Designated as safety issue: No ]
    Investigators will compare the changes in kyphosis measurements, physical function, and HRQOL in response to the intervention exercises between men and women.


Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kyphosis spinal exercises
Investigator developed the intervention protocol (Kyphosis spinal exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video. Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities. All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
Behavioral: Kyphosis spinal strengthening exercises
Investigator developed the intervention protocol (Kyphosis spinal exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video. Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities. All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
No Intervention: Control
Control group will be enrolled in the usual care waitlist group

Detailed Description:

Participants assigned to the intervention group will receive a high-intensity spinal strengthening group exercise program for 1 hour twice per week for 12 weeks, with home practice. The exercise program is outlined below in Table 2. The participants assigned to the control group will be receive usual care and be enrolled in a waitlist group. A physical therapist will teach the high-intensity spine strengthening exercise intervention sessions. Additionally, physical therapy graduate students will attend all exercise sessions to help ensure the safety of all participants and maintain a ratio of no more than five participants to one teacher. Participants in the control group will crossover to the spinal strengthening exercise group after 12 weeks and receive the intervention for 12 weeks.

All potential participants will be screened initially with a medical screening exam, and their primary care provider will be contacted by the study physician for approval for study participation. The participant will sign the medical release giving their primary care provider permission to release medical information to the study physician. The primary outcome will be change in Cobb angle of kyphosis over 12 weeks calculated from measurements taken from lateral spine radiographs and change in the Physical Performance Test (PPT). The investigators will also assess the effect of the exercise intervention on the secondary outcomes of physical function, strength and quality of life. The investigators will also use dual-energy x-ray absorptiometry (DXA) to determine bone mineral density before the study intervention. Study participants will receive an actigraph to measure physical activity throughout the study.

For participants in the control group who crossover to the exercise intervention group at 12 weeks will receive an additional lateral spine radiograph at the end of the intervention.

Both groups will receive a copy of the study exercise DVD at the end of the study.

Table 2. Exercise Intervention Exercises Spinal strengthening exercises (20 mins)10-12 repetitions at 70-80% 1RM Progress from 0 - 5# or theraband Spinal mobility exercises (10 mins) Passive 30 second hold Warm-up (10 mins) Increase core temperature with aerobic warm-up on bike/treadmill Prone trunk lift to neutral Spine mobilization on roller Quadruped arm/leg lift Standing shoulder flexion/thoracic extension Cool-down (5 mins) Bilateral latissimus pull-down on roller Quadruped thoracic extension mobilization Neck and upper extremity stretches Sidelying rotation and extension Spinal alignment (15 mins) Transversus abdominous strengthening Training in bilateral and single leg stance Lower extremity stretches Wall push-ups with spine in neutral Training sit-to stand, squats, lunges Diaphragmatic breathing

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60 years and older
  • kyphosis >=40 degrees
  • medical approval from primary care clinician

Exclusion Criteria:

  • Gait speed <0.6 meters/sec
  • inability to rise from a chair with arms crossed at chest
  • painful vertebral fractures in the past 3 months
  • 3 or more falls in the past year
  • advanced disability or end-stage disease
  • major psychiatric illness
  • cognitive impairment
  • alcohol, drug abuse, or narcotic pain medications
  • uncontrolled hypertension
  • peripheral neuropathy associated with Type I diabetes
  • chest pain, myocardial infarction, or cardiac surgery within the previous 6 months
  • diagnosed vestibular or neurologic disorder
  • total hip or knee replacement or hip fracture within previous 6 months
  • oral glucocorticoid medications for ≥ 3 months the past year
  • no active movement in thoracic spine
  • unable to execute exercise safety tests
  • failure to comply with run-in procedures: poor attendance, or use of actigraph,
  • non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766674

Contacts
Contact: Wendy Katzman, PT,DPTSc,OCS 415-514-6776 wendy.katzman@ucsfmedctr.org
Contact: Shirley S Wong, BS 415-514-6776 wongs@ptrehab.ucsf.edu

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94158
Principal Investigator: Nancy Lane, MD         
Sub-Investigator: Anne Schafer, MD         
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
Investigators
Study Director: Wendy Katzman, PT,DPTSc,OCS University of California, San Francisco
Principal Investigator: Nancy E Lane, MD UC Davis
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01766674     History of Changes
Other Study ID Numbers: P0045190
Study First Received: January 9, 2013
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Kyphosis

Additional relevant MeSH terms:
Kyphosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 01, 2014