EINTER PROGRAM in Spinal Cord Injury Patients

NCT06624566 | Completed

• 1 other identifier: 2024.161
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of the implementation of a therapeutic physical exercise program in a group setting in patients with spinal cord injury admitted to the Miguel Servet University Hospital in Zaragoza. This program consists of performing strength and endurance exercises from Monday to Friday with a duration of approximately 45 minutes each session. The groups are created in such a way that the subjects in each group are homogeneous. This homogeneity is classified according to whether or not trunk control in seated or standing position is maintained in an autonomous manner as measured by the Berg scale. Each group consists of a maximum of 4 subjects and there are a maximum of 2 groups, and 1 physiotherapist per group. Group A is for those subjects who do not maintain independent standing, but maintain trunk control while seated, and group B is for those patients who do maintain independent standing. Prior to the start of the program, subjects are informed of the study and evaluated with a series of health indicators (scales) to measure the impact of the program at the beginning of the program and at hospital discharge. These scales are as follows: To measure muscular strength the investigators use the Medical Research Council, and to measure aerobic endurance the investigators use the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair. In addition, the investigators pass a satisfaction

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injuries; Physical Exercise; resistance; strength; exercise program

Outcome Measures

Primary Outcomes (2)

• Strength

  o Muscular strength measured by Medical Research Council

  From the beginning of the program up to 12 weeks

• Resistance

  o Aerobic endurance measured by the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair.

  From the beginning of the program up to 12 weeks

Secondary Outcomes (1)

• Adherence to the program and level of satisfaction

  From the beginning of the program up to 12 weeks

Study Arms (2)

The A group received a program of therapeutic physical exercise scheduled from Monday to Friday

EXPERIMENTAL

The program protocol for group A consists of: Mondays and Wednesdays: Aerobic circuit protocol (45'). * Warm-up 1-5 min: Global exercises, gentle stretching and range of motion exercises; * Aerobic exercise 30 min, at a target heart rate of 70% FCR in wheelchair. Aerobic exercises will consist of the use of different exercise programs using the "Motomed" type motorized kinesitherapy equipment. * Cool down 5-10 min. Tuesday and Thursday: Strength circuit protocol (45') * Warm up 1-5 min: global exercises, gentle stretching and range of motion exercises. Strength training 30 min: * Concentric and eccentric upper extremity muscle training. Also lower extremity muscle training (hip extensors/flexors and adductors/abductors, knee flexors and extensors, dorsal and plantar ankle flexors). 3 sets/10 repetitions for each exercise at 50-80% RM. * Cool down for 5-10 min. Friday: Combined workout (45'): * 20min aerobic protocol and 15 min strength protocol. * 5-10 min cool down.

Other: Experimental: Implementation of an intensive therapeutic group exercise program in the neurorehabilitation process

The B group received a program of therapeutic physical exercise scheduled from Monday

EXPERIMENTAL

The program protocol for group B consists of: Monday and Wednesday: Aerobic circuit protocol (45'). o Warm-up 1-5 min: Global exercises, gentle stretching and range of motion exercises; aerobic exercises, consisting of graded walking, step or stationary bike, each at a target heart rate of 70% FCR. o Cool down 5-10 min. Tuesday and Thursday: Strength circuit protocol (45') o Warm up 1-5 min: global exercises, gentle stretching and range of motion exercises. o Strength training 30 min: Concentric and eccentric upper extremity muscle training. Also lower extremity muscle training (hip extensors/flexors and adductors/abductors, knee flexors and extensors, dorsal and plantar ankle flexors). 3 sets/10 repetitions for each exercise at 50-80% RM. Cool down for 5-10 min. Friday: Combined workout (45'): o 20min aerobic protocol and 15 min strength protocol. o 5-10 min cool down.

Other: Experimental: Implementation of an intensive therapeutic group exercise program in the neurorehabilitation process

Interventions

Experimental: Implementation of an intensive therapeutic group exercise program in the neurorehabilitation process OTHER

Description: The variables will be measured prior to group assignment The age and sex variables and the satisfaction survey will be measured at the beginning of the program, the other variables at 20 sessions, at 40 sessions, at 60 sessions and/or at hospital discharge. Before the patient starts the program, he/she is classified in group A - patients who have seated trunk control for at least 2 minutes (with supervision) and no standing control (Berg scale item 3.3) - or in group B - patients who have standing trunk control for 2 minutes (with supervision) (Berg scale item 2.3). There is a maximum of 4 patients per group with 1 physiotherapist per group.. There is a maximum of 4 patients per group with 1 physiotherapist per group.. The difference with respect to the usual treatment of the neurorehabilitation service of the HMS is that in the EINTER program, strength and endurance exercises will be implemented in addition to the usual care plan

The A group received a program of therapeutic physical exercise scheduled from Monday to Friday; The B group received a program of therapeutic physical exercise scheduled from Monday

Eligibility Criteria

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

You may qualify if:

• Adult patients 18 years of age or older. Clinical diagnosis of spinal cord injury below C3 admitted to the Neurorehabilitation ward of the Miguel Servet University Hospital.

You may not qualify if:

• Clinical diagnosis of spinal cord injury level at C3 with tetraplegia.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (7)

• Dupepe EB, Davis M, Elsayed GA, Agee B, Kirksey K, Gordon A, Pritchard PR. Inter-rater reliability of the modified Medical Research Council scale in patients with chronic incomplete spinal cord injury. J Neurosurg Spine. 2019 Jan 18;30(4):515-519. doi: 10.3171/2018.9.SPINE18508. Print 2019 Apr 1.

  PMID: 30660112 RESULT

• Solanki R, Chaudhari P, Bhise A. 60 :: Cardio Respiratory Fitness Testing in Spinal Cord Injury Patients Using 6 Minute Push Test Original Article Healthline Journal. 7(1).

  RESULT

• Martin Ginis KA, van der Scheer JW, Latimer-Cheung AE, Barrow A, Bourne C, Carruthers P, Bernardi M, Ditor DS, Gaudet S, de Groot S, Hayes KC, Hicks AL, Leicht CA, Lexell J, Macaluso S, Manns PJ, McBride CB, Noonan VK, Pomerleau P, Rimmer JH, Shaw RB, Smith B, Smith KM, Steeves JD, Tussler D, West CR, Wolfe DL, Goosey-Tolfrey VL. Evidence-based scientific exercise guidelines for adults with spinal cord injury: an update and a new guideline. Spinal Cord. 2018 Apr;56(4):308-321. doi: 10.1038/s41393-017-0017-3. Epub 2017 Oct 25.

  PMID: 29070812 RESULT

• 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 RESULT

• Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.

  PMID: 33239350 RESULT

• Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.

  PMID: 31834165 RESULT

• Bauman WA, Spungen AM. Disorders of carbohydrate and lipid metabolism in veterans with paraplegia or quadriplegia: a model of premature aging. Metabolism. 1994 Jun;43(6):749-56. doi: 10.1016/0026-0495(94)90126-0.

  PMID: 8201966 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: As a quasi-experimental observational study, there is no masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study design Quasi-experimental single-group study with pre-post design. Participants: Inclusion/exclusion criteria o Inclusion criteria: adult patients with 18 years diagnosed with spinal cord injury below C3 admitted to the Neurorehabilitation ward of the Miguel Servet University Hospital. Exclusion criteria: Patients with tetraplegia with level C3.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 3, 2024
• Study Start: January 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)