This Academy member benefit temporarily has been made public to allow all practitioners access to content that may assist in patient care during the national pandemic response. Click here for information on joining the Academy. 

SCI: Role of the Registered Dietitian (2007)

Citation:

Zemper ED, Tate DG, Roller S, Forchmeimer M, Chiodo A, Nelson VS, Scelza W. Assessment of a holistic wellness program for persons with spinal cord injury. Am J Phys Med Rehabil. 2003 Dec; 82(12): 957-68.

PubMed ID: 14627933
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

The role of long-term wellness and health promotion programs in individuals with spinal cord injury have not been assessed.  This study was conducted to identify the benefits in outcomes from a holistic wellness program for persons with spinal cord injury.

Inclusion Criteria:

Inclusion criteria included:

  • Diagnosis of SCI (C5 neurological level of injury or below, American Spinal Injury Association (ASIA) Impairment Classification Scale A–D)
  • 18-80 years of age
  • 1 year post-injury.
Exclusion Criteria:

Exclusion criteria included:

  • presence of associated cognitive deficits preventing learning and carryover (i.e., traumatic brain injury, dementia),
  • medical problems that could impose a health risk (e.g., recent myocardial infarction),
  • a primary disability that was not due to SCI.

 

Description of Study Protocol:

Recruitment

 Patients were recruited from Model SCI Care System database at the University of Michigan hospital and from a mailing list of the local Center for Independent Living. 

Subject acquisition

  • 60 completed a barriers survey indicating reasons for lack of participation interest.
  • 98 completed an interest survey for investigator follow-up.
  • 83 met inclusion criteria after physician screening and completed informed consent
  • 67 attended baseline measurement

Design

 Participants randomly assigned to the control group (n=31) or the intervention group (n=36).  All participants completed clinical assessments at baseline,  2 weeks after end of workshops and 4 month follow-up.  Survey questionnaires were also completed to measure health behaviors, presence of secondary conditions, self-efficacy and overall quality of life.

Blinding used

None  

Intervention

The intervention was a series of six 4-hour workshops ("Well on Wheels") held over 3 months.  The workshop focused on four areas:

  1. Lifestyle managements (including sexual health and stress management)
  2. Physical activity
  3. Nutrition
  4. Preventing secondary conditions

The workshops were didactic and experiential, with individual coaching sessions and two follow-up phone calls during the 4 months following the workshop.  A participants manual was provided to the participants that was prepared by workshop facilitators.  Personal goal setting for the next four months for each participant attending the second assessment was performed.  The follow up phone calls addressed the progress of those goals and included troubleshooting to improve reaching of goals.

Statistical Analysis

Quality control was performed using frequency analysis and descriptive statistics. T-test examined pre- and post-intervention changes in intervention subject scores because the control subjects "did not take part in any intervention, there was no a priori rationale for predicting changes."

Data Collection Summary:

Timing of Measurements

Clinical assessments of medical/physiological outcomes were measured during Saturday morning visits.  These measures included a blood draw, arm crank ergometer, neurological exam, height, weight, body mass index and questionnaires.

Dependent Variables

  • Wellness file-II (HPLP) with subscales for health responsibility, nutrition, stress management, physical activity
  • Secondary Conditions Scale for conditions in the past three months
  • Self-related Abilities for Health Practices Scale (SAHP) to assess individual perception of ability for maintaining a healthy lifestyle
  • Perceive Stress Scale
  • Physical Activities with Disability Questionnaire (PADS) with subscales for exercise, leisure activity and household activity

Independent Variables

 Intervention vs control groups

Control Variables

 Control for employment status and educational attainment is multivariate models.

Description of Actual Data Sample:

 

Initial N: 67 were randomly assigned to treatment (n=36) and control (n=31) groups.  Data for gender and sociodemographics were only provided for those providing all data.  Information provided below reflect only full follow-up data.

Attrition (final N):

Of the 43 persons who fully completed all phases of the study, 23 were intervention subjects and 20 were members of the control group. Neurologically, the sample was categorized:
  • 65% complete injuries (ASIA A) and 35% incomplete (ASIA B–D),
  • 19% incomplete paraplegic, 35% complete paraplegic, 16% incomplete tetraplegic, and 30% complete tetraplegic.
  • 19% was ambulatory (i.e., they did not use a wheelchair and walked either with or without the use of aids such as canes or crutches).

Age: Intervention (44 years Mean, 23-74); Control (50 years, 22-80)

Ethnicity: Intervention (21 White, 9 African American); Control (19 White, 1 African American)

Other relevant demographics:

 

Intervention
(n=23)

Control
(n=20)
Years since injury 13 (2-34) 16 (1-49)
Married 10 (43%) 13 (65%)
Employed full-time 5 (22%) 6 (30%)

Anthropometrics

Location: University of Michigan hospital

 

Summary of Results:

There were no significant changes in any measure from baseline to final follow-up for those in the control groups.  Significant improvements were found from baseline to follow-up for the following scales for intervention subjects:

  • Self-Rated Abilities for Health Practices Scale (88.04 to 95.39, P<0.05)
  • Health Promoting Lifestyle Profile (HPLP-II) Total Score (2.43 to 2.7, P<0.001)
    • Health responsibility subscale (2.53 to 2.83, P<0.001)
    • Health Nutrition subscale (2.28 to 2.53, P<0.05)
    • Stress management subscale (2.34 to 2.68, P<0.001)
    • Physical activity subscale (1.86 to 2.24, P<0.001)
  • Perceived Stress Scale (24.00 to 21.26, P<0.05)
  • Secondary conditions scale (27.04 to 17.48, P<0.001)
    • Total number of secondary conditions (15.83 to 11.04, P<0.01) 

Other Findings

No significant differences for either group from baseline to follow-up for body mass index, any data from the ergometer (total work , total time) or total cholesterol (mg per dL).

Mean intensity scores were significantly reduced from follow-up to baseline in the intervention group for:
joint and muscle pain; physical fitness and conditioning problems; sexual dysfunction; eating or weight problems; anger; bowel dysfunction; urinary tract infection; and carpal tunnel syndrome.

Author Conclusion:

Self-efficacy is a valuable component to wellness programming for those with SCI.  The workshops were able to elicit changes in several of the measures of self-efficacy, lifestyle behaviors and physical fitness, as changes in metabolic parameters were not expected in such a short period of time.

Funding Source:
Government: NIH, NIDRR
University/Hospital: University of Michigan Health Systems
Reviewer Comments:

If the study was originally intended to serve as a pilot study, this was not evident until the end of the manuscript.  There were several areas of the design and implementation that were unclear or not described.  The statistical analyses were improperly performed.  Even though the authors did not expect a change in the control group, multiple t-tests of pre- and post-data for the control and intervention groups, separately, increase the risk of type 1 error, as well as defeat the purpose of the RCT design.

The manuscript was difficult to assess due to several missing components of the design and the scattered nature of the information.

Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? No
  4.1. Were follow-up methods described and the same for all groups? No
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) No
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? No
  4.4. Were reasons for withdrawals similar across groups? ???
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? ???
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) ???
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? No
  7.1. Were primary and secondary endpoints described and relevant to the question? No
  7.2. Were nutrition measures appropriate to question and outcomes of concern? No
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? No
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  7.5. Was the measurement of effect at an appropriate level of precision? No
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? ???
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes