Intervention Study to Assess the Effects of Moderate and High Intensity Aerobic Training on Physical Capacity and Activity Level in Persons With Incomplete Spinal Cord Injury

NCT01903226 | Completed DMC

• 1 other identifier: SPREK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to assess the effects of medium versus high intensity 12-week adjusted training programs on physical capacity in persons with incomplete SCI, early after discharge from primary rehabilitation, and to investigate if the training program induces a more active lifestyle in terms of increased daily energy expenditure.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; physical capacity; energy expenditure; training

Outcome Measures

Primary Outcomes (1)

• change in VO2peak

  Physical capacity (VO2peak) will be measured before intervention (baseline), after 3 months and after 1 year (12 months. Changes (from baseline) in VO2peak after 3 months and after one year is the primary outcome measure.

  0 months, 3 months and 12 months

Study Arms (3)

High intensity training

EXPERIMENTAL

Patients in this group will perform high aerobic intensity training, in 30 minutes, twice a week, in a 12 week period.

Other: High intensity training

Moderate intensity training

EXPERIMENTAL

Patients in this group will perform moderate aerobic intensity training, in 45 minutes, three times a week, in a 12 week period.

Other: Moderate intensity training

controll

NO INTERVENTION

Patients in this group will perform no (additional) training.

Interventions

High intensity training OTHER

High intensity training

Moderate intensity training OTHER

Moderate intensity training

Eligibility Criteria

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

You may qualify if:

• Spinal cord injury
• incomplete lesion (classified as ASIA D)
• admitted to Sunnaas Rehabilitation Hospital for primary rehabilitation,
• able to walk for 5 minutes on the treadmill (without assistive aids) at 4 km/hour

You may not qualify if:

• cardiovascular diseases
• progressive diseases
• severe psychiatric conditions

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, 1450, Norway

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 19, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

NO (1)