Exercise for People with Spinal Cord Injury

NCT04007445 | Completed

• 1 other identifier: 201701143
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine the impact of a transitional exercise intervention implemented in the community for people with SCI on psychological well-being, social factors, and physiological health.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; exercise; occupational therapy

Outcome Measures

Primary Outcomes (6)

• PROMIS - Change in Fatigue (Short Form 8a)

  The Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely impacts one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue and the impact of fatigue. The fatigue short forms are not disease specific and assess fatigue over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

  Baseline, post intervention and 3 month follow-up

• PROMIS - Change in Emotional Distress - Depression (Short Form 8a)

  The Depression item banks assess self-reported negative mood (sadness, guilt), views of self(self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as changed positive affect and engagement (loss of interest, meaning, and purpose). The depression short forms are not disease specific and assess depression over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "never (1)" to "always (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

  Baseline, post intervention and 3 month follow-up

• PROMIS - Change in Pain Intensity (Short Form 3a)

  The Pain Intensity instruments assess how much a person hurts. The pain intensity short forms are not disease specific and assess pain intensity over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "Had no pain (1)" to "very severe (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

  Baseline, post intervention and 3 month follow-up

• PROMIS - Change in Pain Interference (Short Form 8a)

  The Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It also incorporates items probing sleep and enjoyment in life. The pain interference short forms are not disease specific and assess pain interference over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

  Baseline, post intervention and 3 month follow-up

• PROMIS - Change in Sleep Disturbance (Short Form 8a)

  The Sleep disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The sleep disturbance short forms are not disease specific and assess sleep disturbances over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "very poor (1)" to "very good (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

  Baseline, post intervention and 3 month follow-up

• PROMIS - Change in Emotional Support

  The Emotional support item banks assess perceived feelings of being cared for and valued as a person; having confident relationships. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "never (1)" to "always (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

  Baseline, post intervention and 3 month follow-up

Secondary Outcomes (2)

• The Exercise Self-Efficacy Scale (ESES)

  Baseline, post intervention, 3 month follow-up

• RM 4-FM: Motivation for Physical Activity and Exercise/Working Out - Questionnaire

  Baseline, post intervention, 3-month follow-up

Study Arms (2)

Formally Directed Group (Exercise Group)

ACTIVE COMPARATOR

A group performing a 12 - week guided exercise program at an accessible Community Health and Wellness Center

Behavioral: Formally Directed Group (Exercise Group)

Self-Directed Group (Control Group)

PLACEBO COMPARATOR

A group receiving educational information about physical activity and exercise at home and then self-directing a 12 - week exercise program on their own.

Other: Self-Directed Group (Control Group)

Interventions

Formally Directed Group (Exercise Group) BEHAVIORAL

This group will receive a 12-week exercise intervention that will educate and support the person's ability to exercise. Working with a trainer, the participant will attend a 12-week (3 x week) exercise program that has been personalized to their goals. Each session will include warm-up, stretching, cardiovascular exercises, strength exercises, and cool-down. Each session will be 1-2 hours in duration. The participants may wear accelerometers and heart rate monitors to help determine the level of intensity of the exercises, as they should be performing at least 150 minutes of moderate to vigorous exercise each week. By the end of the 12-week program, the goal is for participants to guide their own exercise regimens.

Formally Directed Group (Exercise Group)

Self-Directed Group (Control Group) OTHER

This group will receive a 1-hour education session during which they will learn about the National Council on Health, Physical Activity and Disability (NCHPAD) website, an information and resource center on health promotion for people with disabilities. During the session participants will be given an overview of the website and asked to find three resources they find of interest. Their strength and fitness will also be assessed by completing a 1-rep max test. The participants will then be asked to maintain their regular physical activity for the next 12 weeks and complete a weekly physical activity log to track their exercise participation. A staff member will phone each person every week for the 12-week period and have the participant report his or her physical activity during the week.

Self-Directed Group (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants will be excluded if they are medically unstable, have a cognitive impairment that does not allow them to provide consent, are currently or have previously been participants in the PQHWC or community-based exercise program, or have been enrolled in a structured exercise program over the past six months.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (11)

• Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: psychometric properties of a measure of participation for people with mobility impairments and limitations. Arch Phys Med Rehabil. 2006 Feb;87(2):189-97. doi: 10.1016/j.apmr.2005.09.014.

  PMID: 16442971 BACKGROUND

• Miller LC, Gottlieb M, Morgan KA, Gray DB. Interviews with employed people with mobility impairments and limitations: environmental supports impacting work acquisition and satisfaction. Work. 2014;48(3):361-72. doi: 10.3233/WOR-131784.

  PMID: 24284677 BACKGROUND

• Kroll T, Kehn M, Ho PS, Groah S. The SCI Exercise Self-Efficacy Scale (ESES): development and psychometric properties. Int J Behav Nutr Phys Act. 2007 Aug 30;4:34. doi: 10.1186/1479-5868-4-34.

  PMID: 17760999 BACKGROUND

• American College of Sports Medicine. (2010). ACSM's Guidelines for Exercise Testing and Prescription. 8th ed. Philadelphia: Lippincott Williams & Wilkins.

  BACKGROUND

• Kroll T, Barbour R, Harris J. Using focus groups in disability research. Qual Health Res. 2007 May;17(5):690-8. doi: 10.1177/1049732307301488.

  PMID: 17478650 BACKGROUND

• Krueger RA, Casey MA. (2009). Focus Groups: A Practical Guide For Applied Research 4th ed. Thousand Oaks, CA: Sage.

  BACKGROUND

• White GW, Suchowierska M, Campbell M. Developing and systematically implementing participatory action research. Arch Phys Med Rehabil. 2004 Apr;85(4 Suppl 2):S3-12. doi: 10.1016/j.apmr.2003.08.109.

  PMID: 15083417 BACKGROUND

• Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.

  PMID: 23499781 BACKGROUND

• Ginis KA, Arbour-Nicitopoulos KP, Latimer AE, Buchholz AC, Bray SR, Craven BC, Hayes KC, Hicks AL, McColl MA, Potter PJ, Smith K, Wolfe DL. Leisure time physical activity in a population-based sample of people with spinal cord injury part II: activity types, intensities, and durations. Arch Phys Med Rehabil. 2010 May;91(5):729-33. doi: 10.1016/j.apmr.2009.12.028.

  PMID: 20434610 BACKGROUND

• Jelleyman C, Yates T, O'Donovan G, Gray LJ, King JA, Khunti K, Davies MJ. The effects of high-intensity interval training on glucose regulation and insulin resistance: a meta-analysis. Obes Rev. 2015 Nov;16(11):942-61. doi: 10.1111/obr.12317.

  PMID: 26481101 BACKGROUND

• Cowan RE, Callahan MK, Nash MS. The 6-min push test is reliable and predicts low fitness in spinal cord injury. Med Sci Sports Exerc. 2012 Oct;44(10):1993-2000. doi: 10.1249/MSS.0b013e31825cb3b6.

  PMID: 22617394 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Kerri A Morgan, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy and Neurology

Model Details: The proposed project utilizes a mixed methods approach. An experimental strategy using a randomized control trial (single-blinded) will be used to assess the efficacy of an established transitional, community-based exercise intervention on people with SCI. Qualitative methods will be used to gather information related to optimizing implementation of a community-based exercise intervention. This project will be conducted in conjunction with Paraquad, a local independent living center. Forty participants will be randomized into an Exercise Group (EG) or Control Group (CG) by the statistician who will not be involved in either conducting outcome assessments or implementation of the intervention. This design will assist in reducing variability and maximizing the effect size for powering subsequent larger randomized control trials.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: April 1, 2017
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: March 28, 2025

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)