Evidence map›Paper›PMID 35614404›Full record

ArticleBMC musculoskeletal disorders2022

A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial.

K F Reid, T W Storer, K M Pencina, R Valderrabano, N K Latham, L Wilson, C Ghattas, R Dixon, A Nunes, N Bajdek and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC musculoskeletal disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03576001 (Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03576001 phase2completednot on this map

Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury

TypeinterventionalSponsorBrigham and Women's HospitalRan2019 to 2025Enrolled84ConditionsSpinal Cord InjuriesArmsTestosterone Undecanoate, hybrid exercise
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 2 institutions in 1 country.

K F ReidResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. kfreid@bwh.harvard.edu.ORCID http://orcid.org/0000-0001-9652-5319
T W StorerResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
K M PencinaResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
R ValderrabanoResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
N K LathamResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
L WilsonResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
C GhattasResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
R DixonResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
A NunesResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
N BajdekResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
G HuangResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
S E SkeelsResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
A P LinCenter for Clinical Spectroscopy, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
S M MerugumalaCenter for Clinical Spectroscopy, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
H J LiaoCenter for Clinical Spectroscopy, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
M L BouxseinCenter for Advanced Orthopaedic Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
R D ZafonteDepartment of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
S BhasinResearch Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center for Function Promoting Therapies, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Brigham and Women's Hospital · USBeth Israel Deaconess Medical Center · US

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
TUFTS--FIELDINGP30AG031679 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI SHALENDER BHASIN · 2008 to 2026
$23.9M
Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury-supplementR01HD093724 · NICHD · BRIGHAM AND WOMEN'S HOSPITAL · PI BHASIN, SHALENDER · 2018 to 2023
$5.3M
NCATS NIH HHS UL1 TR002541NIA NIH HHS P30 AG031679NICHD NIH HHS R01 HD093724
6 · The paper itself

Abstract

backgroundA spinal cord injury (SCI) is a devastating, life-changing event that has profoundly deleterious effects on an individual's health and well-being. Dysregulation of neuromuscular, cardiometabolic, and endocrine organ systems following an SCI contribute to excess morbidity, mortality and a poor quality of life. As no effective treatments currently exist for SCI, the development of novel strategies to improve the functional and health status of individuals living with SCI are much needed. To address this knowledge gap, the current study will determine whether a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that consists of functional electrical stimulation of the lower extremity during leg cycling (FES-LC) plus arm ergometry (AE) administered using behavioral motivational strategies, and testosterone therapy, is more efficacious than FES-LC plus AE and placebo in improving aerobic capacity, musculoskeletal health, function, metabolism, and wellbeing in SCI.

methodsThis single-site, randomized, placebo-controlled, parallel group trial will enroll 88 community-dwelling men and women, 19 to 70 years of age, with cervical and thoracic level of SCI, ASIA Impairment Scale grade: A, B, C, or D, 6 months or later after an SCI. Participants randomized to the multimodality intervention will undergo 16 weeks of home-based FES-LC and AE training plus testosterone undecanoate. Testosterone undecanoate injections will be administered by study staff in clinic or by a visiting nurse in the participant's home. The control group will receive 16 weeks of home-based FES-LC and AE exercise plus placebo injections. The primary outcome of this trial is peak aerobic capacity, measured during an incremental exercise testing protocol. Secondary outcomes include whole body and regional lean and adipose tissue mass; muscle strength and power; insulin sensitivity, lipids, and inflammatory markers; SCI functional index and wellbeing (mood, anxiety, pain, life satisfaction and depressive symptoms); and safety. DISCUSSION: We anticipate that a multimodality intervention that simultaneously addresses multiple physiological impairments in SCI will result in increased aerobic capacity and greater improvements in other musculoskeletal, metabolic, functional and patient-reported outcomes compared to the control intervention. The findings of this study will have important implications for improving the care of people living with an SCI.

trial registrationClinicalTrials.gov :  ( NCT03576001 ). Prospectively registered: July 3, 2018.

Indexed as

Quality of LifeSpinal Cord InjuriesAdultAgedExercise TherapyFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicRecovery of FunctionTreatment OutcomeAndrogen therapyExerciseMultimodality interventionSpinal cord injury

Identifiers

PMID35614404
PMCPMC9130453
OpenAlexW4281477630

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.