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

NCT01766674 | Completed

• 1 other identifier: P0045190
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Kyphosis

Keywords

Kyphosis

Outcome Measures

Primary Outcomes (1)

• Effect of exercise intervention on kyphosis

  Investigators will measure change in Cobb angle on lateral spine radiograph.

  3-month post baseline

Secondary Outcomes (1)

• Effect of exercise intervention on physical function

  3-month post baseline

Other Outcomes (6)

• Effect of exercise intervention on health related quality of life (HRQOL)

  3-month post baseline

• Effect of exercise intervention on kyphosis

  6month post baseline for crossovers

• Effect of exercise intervention on physical function

  6month post baseline for crossovers

Study Arms (2)

Kyphosis spinal exercises

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group will be enrolled in the usual care waitlist group

Interventions

Kyphosis spinal strengthening exercises BEHAVIORAL

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.

Kyphosis spinal exercises

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94158, United States

Location

Related Publications (2)

• 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.

  PMID: 33618669 DERIVED

• 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.

  PMID: 29202732 DERIVED

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Wendy Katzman, PT,DPTSc,OCS

  University of California, San Francisco

  STUDY DIRECTOR

• Nancy E Lane, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 11, 2013
• Study Start: February 1, 2013
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

US (1)