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

Primary Purpose

Kyphosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kyphosis spinal strengthening exercises
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kyphosis focused on measuring Kyphosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kyphosis spinal exercises

Control

Arm Description

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.

Control group will be enrolled in the usual care waitlist group

Outcomes

Primary Outcome Measures

Effect of exercise intervention on kyphosis
Investigators will measure change in Cobb angle on lateral spine radiograph.

Secondary Outcome Measures

Effect of exercise intervention on physical function
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

Full Information

First Posted
January 9, 2013
Last Updated
November 12, 2019
Sponsor
University of California, San Francisco
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01766674
Brief Title
Specialized Centers of Research (SCOR)on Sex Differences - Kyphosis Study
Acronym
SCOR
Official Title
Specialized Centers of Research (SCOR) Kyphosis Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
May 31, 2016 (Actual)
Study Completion Date
May 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis
Keywords
Kyphosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kyphosis spinal exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will be enrolled in the usual care waitlist group
Intervention Type
Behavioral
Intervention Name(s)
Kyphosis spinal strengthening exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of exercise intervention on kyphosis
Description
Investigators will measure change in Cobb angle on lateral spine radiograph.
Time Frame
3-month post baseline
Secondary Outcome Measure Information:
Title
Effect of exercise intervention on physical function
Description
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
Time Frame
3-month post baseline
Other Pre-specified Outcome Measures:
Title
Effect of exercise intervention on health related quality of life (HRQOL)
Description
Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health Questionnaires.
Time Frame
3-month post baseline
Title
Effect of exercise intervention on kyphosis
Description
Investigators will measure change in Cobb angle on lateral spine radiograph
Time Frame
6month post baseline for crossovers
Title
Effect of exercise intervention on physical function
Description
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
Time Frame
6month post baseline for crossovers
Title
Effect of exercise intervention on health related quality of life (HRQOL)
Description
Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health Questionnaires.
Time Frame
6month post baseline for crossovers
Title
Difference in baseline characteristics and intervention effects in kyphosis in men and women
Description
Investigators will compare the changes in kyphosis measurements, physical function, and HRQOL in response to the intervention exercises between men and women.
Time Frame
3month post baseline
Title
Difference in baseline characteristics and intervention effects in kyphosis in men and women
Description
Investigators will compare the changes in kyphosis measurements, physical function, and HRQOL in response to the intervention exercises between men and women.
Time Frame
6month post baseline for crossovers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Katzman, PT,DPTSc,OCS
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nancy E Lane, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33618669
Citation
Gladin A, Katzman WB, Fukuoka Y, Parimi N, Wong S, Lane NE. Secondary analysis of change in physical function after exercise intervention in older adults with hyperkyphosis and low physical function. BMC Geriatr. 2021 Feb 22;21(1):133. doi: 10.1186/s12877-021-02062-8.
Results Reference
derived
PubMed Identifier
29202732
Citation
Katzman WB, Parimi N, Gladin A, Poltavskiy EA, Schafer AL, Long RK, Fan B, Wong SS, Lane NE. Sex differences in response to targeted kyphosis specific exercise and posture training in community-dwelling older adults: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Dec 4;18(1):509. doi: 10.1186/s12891-017-1862-0.
Results Reference
derived

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

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