Restorative Exercise for Strength Training and Operationa... | NCT02132910

Restorative Exercise for Strength Training and Operationa... | NCT02132910 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RESTORE Intervention	Experimental	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health.	Other: RESTORE Intervention
Control Group 2	No Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.

Name	Type	Description	Arm Group Labels	Other Names
RESTORE Intervention	Other		RESTORE Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Scores	Participants will choose a pain score using the Defense and Veteran's Pain Rating Scale 2.0 Rate the severity of your CURRENT pain: 0 - No Pain - Hardly notice pain - Notice pain, does not interfere with activities - Sometimes distracts me - Distracts me, can do usual activities - Interrupts some activities - Hard to ignore, avoid usual activities - Focus of attention, prevents doing daily activities - Awful, hard to do anything - Can't bear pain, unable to do anything - As bad as it could be, nothing else matters Higher values represent worse outcomes	Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Disability	The Roland Morris Disability Questionnaire is reliable at measuring level of disability and is sensitive to change over time for groups of patients with lower back pain. Scale: 0-24 (24 total statements) -Greater levels of disability are reflected by higher numbers on a 24-point scale See link for complete statements: https://www.worksafe.qld.gov.au/\_\_data/assets/pdf\_file/0009/76851/roland-morris-low-back-pain-and-disability-questionnaire-rmq1.pdf

Other Outcomes

Measure	Description	Time Frame
Physical Functioning	Physical functioning was assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Functioning subscale (0-100) Total scores are transformed to standardized t scores (mean=50; SD=10). Higher scores indicate higher physical functioning.	Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

Contacts/Locations Module

Name	Affiliation	Role
Chester Buckenmaier, MD	Defense and Veterans Center for Integrative Pain Management	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed National Military Medical Center		Bethesda	Maryland	20889	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28919191	Derived	Highland KB, Schoomaker A, Rojas W, Suen J, Ahmed A, Zhang Z, Carlin SF, Calilung CE, Kent M, McDonough C, Buckenmaier CC 3rd. Benefits of the Restorative Exercise and Strength Training for Operational Resilience and Excellence Yoga Program for Chronic Low Back Pain in Service Members: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jan;99(1):91-98. doi: 10.1016/j.apmr.2017.08.473. Epub 2017 Sep 14.

Arm/Group Information

ID	Title	Description
FG000	RESTORE Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health. RESTORE Intervention
FG001	Control Group 2	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00034 subjects FG00134 subjects
COMPLETED		FG00034 subjects FG00134 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	RESTORE Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health. RESTORE Intervention

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pain Scores

Participants will choose a pain score using the Defense and Veteran's Pain Rating Scale 2.0

Rate the severity of your CURRENT pain:

0 - No Pain

- Hardly notice pain
- Notice pain, does not interfere with activities
- Sometimes distracts me
- Distracts me, can do usual activities
- Interrupts some activities
- Hard to ignore, avoid usual activities
- Focus of attention, prevents doing daily activities
- Awful, hard to do anything
- Can't bear pain, unable to do anything
- As bad as it could be, nothing else matters

Higher values represent worse outcomes

Posted

Mean

Standard Deviation

units on a scale

Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up

ID	Title	Description
OG000	Control Group 2	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RESTORE Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health. RESTORE Intervention

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chester Buckenmaier	DVCIPM	301-816-4710		cbuckenmaier@dvcipm.org

Condition Browse Module

ID	Term
D017116	Low Back Pain

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0004.32± 1.61 OG0014.68± 1.51

Midtreatment

Title	Measurements
	OG0003.97± 1.71 OG0012.60± 1.83

Posttreatment

Title	Measurements
	OG0003.67± 1.86 OG0012.48± 2.34

3 month follow up

Title	Measurements
	OG0003.35± 1.79 OG0012.75± 2.43

6 month follow up

Title	Measurements
	OG0002.86± 2.01 OG0012.79± 2.34

Secondary

Disability

The Roland Morris Disability Questionnaire is reliable at measuring level of disability and is sensitive to change over time for groups of patients with lower back pain.

Scale: 0-24 (24 total statements)

-Greater levels of disability are reflected by higher numbers on a 24-point scale See link for complete statements: https://www.worksafe.qld.gov.au/\_\_data/assets/pdf\_file/0009/76851/roland-morris-low-back-pain-and-disability-questionnaire-rmq1.pdf

Posted

Mean

Standard Deviation

units on a scale

Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

ID	Title	Description
OG000	Control Group 2	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.
OG001	RESTORE Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health. RESTORE Intervention

Units	Counts
Participants	OG00034 OG00134

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0008.68± 4.82 OG0019.21± 4.91

Midtreatment

Title	Measurements
	OG000

Other Pre-specified

Physical Functioning

Physical functioning was assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Functioning subscale (0-100) Total scores are transformed to standardized t scores (mean=50; SD=10). Higher scores indicate higher physical functioning.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

ID	Title	Description
OG000	Control Group 2	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.
OG001	RESTORE Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health. RESTORE Intervention

Units	Counts
Participants	OG00034 OG00134

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00042.03± 5.29 OG00140.67± 3.71

Midtreatment

Title	Measurements
	OG000

Other Pre-specified

Symptom Burden

Symptom burden was assessed using the PROMIS-29 Sleep Disturbance, Pain Interference, Anxiety, Depression, and Fatigue subscales (0-100) Subscales are averaged into a composite score.The Composite scale ranges from 0 to 100, with higher scores indicating higher symptom burden.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up

ID	Title	Description
OG000	Control Group 2	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform so simple physical assessments, and answer questions about yourself, your pain and your current medication use. You will be contacted once a week for eight weeks by phone or email to answer questions about your pain level. At weeks four and eight, you will repeat the assessment of pain, physical function and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavior health.
OG001	RESTORE Intervention	First you will receive an initial assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about yourself, your pain and your current medication use. For the first four weeks you will receive twice-weekly, individualized, hour-long RESTORE sessions from a specially trained RESTORE instructor. For the next four weeks, you will receive weekly, individualized, hour-long RESTORE sessions from a RESTORE instructor. At weeks four and eight, you will repeat the assessment of pain, physical function, and behavioral health. You will be asked to take a computer questionnaire, perform some simple physical assessments, and answer questions about pain and medication use. At three and six months, you will be contacted by telephone or email to answer questionnaires about pain, physical function, and behavioral health. RESTORE Intervention

Units	Counts
Participants	OG00034 OG00134

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00053.90± 5.23 OG00154.90± 5.72

Midtreatment

Title	Measurements
	OG000