Trial Outcomes & Findings for Study of Hyperkyphosis, Exercise and Function-SHEAF (NCT NCT01751685)

Results Overview

The primary outcome is change in kyphosis from baseline to 6 months, measured using the gold standard Cobb angle of kyphosis derived from standing lateral spine radiographs and a standardized protocol for thoracic kyphosis (T4-T12). The study team performed exploratory analyses using the centroid method for measuring Cobb angle from lateral spine radiograph and the Debrunner kyphometer external measurement of kyphosis. Participants stood barefoot with knees straight and arms supported at 90° of flexion; they were instructed to hold full inhalation for the duration of the scan. Measurements were made by a trained radiologist (BF) who read the radiographs paired by participant but blinded to group allocation. A greater Cobb angle indicates more kyphosis severity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2023-03-07

Participant Flow

Speaks English, age ≥60 years, kyphosis angle ≥40° by the Debrunner kyphometer measured at the screening visit, and ability to walk one block without the use of an assistive device, climb one flight of stairs independently, and rise from a chair without the use of one's arms. Participants were excluded for inability to straighten the thoracic spine at least 5°, cognitive impairment, inability to pass safety tests in screening or any disorder or disease likely to interfere with safe participation

Participant milestones

Participant milestones
Measure	Kyphosis-specific Spinal Exercises Investigator developed the intervention protocol (Kyphosis-specific 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-specific spinal strengthening exercises: Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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 Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes. Control: monthly educational lectures on various topics
6-mo Followup STARTED	51	48
6-mo Followup COMPLETED	48	45
6-mo Followup NOT COMPLETED	3	3
12-mo Followup STARTED	48	45
12-mo Followup COMPLETED	43	45
12-mo Followup NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Kyphosis-specific Spinal Exercises Investigator developed the intervention protocol (Kyphosis-specific 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-specific spinal strengthening exercises: Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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 Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes. Control: monthly educational lectures on various topics
6-mo Followup Missed study visit	1	0
6-mo Followup Withdrawal by Subject	2	2
6-mo Followup Lost to Follow-up	0	1
12-mo Followup Lost to Follow-up	5	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kyphosis-specific Spinal Exercises n=51 Participants Investigator developed the intervention protocol (Kyphosis-specific 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-specific spinal strengthening exercises: Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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 n=48 Participants Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes. Control: monthly educational lectures on various topics	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=51 Participants	0 Participants n=48 Participants	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=51 Participants	0 Participants n=48 Participants	0 Participants n=99 Participants
Age, Categorical >=65 years	51 Participants n=51 Participants	48 Participants n=48 Participants	99 Participants n=99 Participants
Age, Continuous	71.0 years n=51 Participants	70.2 years n=48 Participants	70.6 years n=99 Participants
Sex: Female, Male Female	35 Participants n=51 Participants	36 Participants n=48 Participants	71 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=51 Participants	12 Participants n=48 Participants	28 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	51 participants n=51 Participants	48 participants n=48 Participants	99 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

The primary outcome is change in kyphosis from baseline to 6 months, measured using the gold standard Cobb angle of kyphosis derived from standing lateral spine radiographs and a standardized protocol for thoracic kyphosis (T4-T12). The study team performed exploratory analyses using the centroid method for measuring Cobb angle from lateral spine radiograph and the Debrunner kyphometer external measurement of kyphosis. Participants stood barefoot with knees straight and arms supported at 90° of flexion; they were instructed to hold full inhalation for the duration of the scan. Measurements were made by a trained radiologist (BF) who read the radiographs paired by participant but blinded to group allocation. A greater Cobb angle indicates more kyphosis severity.

Outcome measures

Outcome measures
Measure	Kyphosis-specific Spinal Exercises n=51 Participants Investigator developed the intervention protocol (Kyphosis-specific 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-specific spinal strengthening exercises: Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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 n=48 Participants Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes. Control: monthly educational lectures on various topics
Change in Cobb Angle of Kyphosis	-3.3 Degrees Interval -4.9 to -1.7	-0.3 Degrees Interval -1.9 to 1.2

SECONDARY outcome

Timeframe: Baseline and 6 months

Modified Physical Performance Test (PPT) is a composite measure of physical function in aging adults: 50ft \[15.2-m\] floor walk, putting on and removing a laboratory coat, picking up a penny from the floor, standing up 5 times from a 40.6cm-high \[16in-high\] chair without the use of arms, lifting a 7-lb book to a shelf, climbing one flight of stairs, and standing with feet together) and 2 additional untimed tasks (climbing up and down 4 flights of stairs and performing a 360° turn). The test involves 9 functional items, 4 points per item; the range is 0-36 points, and higher values represent a higher physical performance.

Outcome measures

Outcome measures
Measure	Kyphosis-specific Spinal Exercises n=51 Participants Investigator developed the intervention protocol (Kyphosis-specific 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-specific spinal strengthening exercises: Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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 n=48 Participants Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes. Control: monthly educational lectures on various topics
Change in Modified Physical Performance Test (PPT)	0.3 Score on a scale Interval -0.2 to 0.8	0.8 Score on a scale Interval 0.3 to 1.3

Adverse Events

Kyphosis-specific Spinal Exercises

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Kyphosis-specific Spinal Exercises n=51 participants at risk Investigator developed the intervention protocol (Kyphosis-specific 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-specific spinal strengthening exercises: Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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 n=48 participants at risk Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes. Control: monthly educational lectures on various topics
Musculoskeletal and connective tissue disorders Falls	25.5% 13/51 • Number of events 13 • 1 year Participants are asked to report adverse events to the study staff. Serious adverse events (death, life-threatening adverse experiences, related inpatient hospitalization) will be reported to the University of California, San Francisco Committee on Human Subjects Research in 5 days.	16.7% 8/48 • Number of events 8 • 1 year Participants are asked to report adverse events to the study staff. Serious adverse events (death, life-threatening adverse experiences, related inpatient hospitalization) will be reported to the University of California, San Francisco Committee on Human Subjects Research in 5 days.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	58.8% 30/51 • Number of events 30 • 1 year Participants are asked to report adverse events to the study staff. Serious adverse events (death, life-threatening adverse experiences, related inpatient hospitalization) will be reported to the University of California, San Francisco Committee on Human Subjects Research in 5 days.	25.0% 12/48 • Number of events 12 • 1 year Participants are asked to report adverse events to the study staff. Serious adverse events (death, life-threatening adverse experiences, related inpatient hospitalization) will be reported to the University of California, San Francisco Committee on Human Subjects Research in 5 days.

Additional Information

Wendy Katzman, PT

University of California, San Francisco

Phone: 415-353-7598

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place