NCT02319122

Brief Summary

The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (High Intensity Interval Training and Progressive Resistance Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

December 10, 2014

Last Update Submit

December 21, 2017

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyMuscle structureStrength training

Outcome Measures

Primary Outcomes (1)

  • Change in time for 6 minute Walk Test

    The 6 minute walk test is a self-paced, submaximal test that assesses functional capacity for walking a prolonged distance. The distance reached within 6 minutes of walking is evaluated.

    between baseline and 2 months later (end of intervention)

Secondary Outcomes (11)

  • Change in time for Muscle Power Sprint Test

    between baseline and 2 months later (end of intervention)

  • Change in Range of Motion measurements (Goniometer)

    between baseline and 2 months later (end of intervention)

  • Change in Spasticity measurements (Modified Ashworth Scale)

    between baseline and 2 months later (end of intervention)

  • Change in time for Timed Up and Go Test

    between baseline and 2 months later (end of intervention)

  • Change in time for Timed Stair Test

    between baseline and 2 months later (end of intervention)

  • +6 more secondary outcomes

Study Arms (2)

Progressive Resistance Training

OTHER

The key for the PRT is the timely progression of load, based on the child's individual level of strength, which ensures progressive overload. Every training session will consist of a warm up, progressive resistance exercises and a cool down period. During warm up and cool down periods.These exercises will be the same for both training groups. The strength training exercises have been chosen to strengthen the main lower extremity muscle groups which are important for the gait: sit-to-stand, lateral step-ups, the half knee rise, heel-rises and bridging. All these exercises are performed loaded according to the individual level. Three sets of 8 to 10 repetitions of each exercise will be practiced on 3 non-consecutive days with moderate velocity.

Other: Progressive Resistance Training

High Intensity Interval Training

OTHER

The High Intensity Circuit Training is a sub form of High Intensity Interval Training. The key feature is the very little rest between the exercises which causes a consistent elevation of the participant's heart rate and a short duration of the whole exercise session. Every training session consists of a warm-up, a circuit of 5 exercises (the same as these in the PRT group) and a cool-down period. The children will be asked to train 3 times a week on non-consecutive days and to perform 3 sets. Exercise workload is controlled by determination of time intervals (30 seconds). The children will be instructed to perform as many repetitions as possible during the exercise interval and to keep the rest between the exercises short (it must not exceed 30 seconds).

Other: High Intensity Interval Training

Interventions

High Intensity Interval TrainingOTHER

See arm description

Also known as: HIIT
High Intensity Interval Training
Progressive Resistance TrainingOTHER

See arm description

Also known as: PRT
Progressive Resistance Training

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ambulatory children with unilateral or bilateral spastic cerebral palsy
  • Age between 8-16 years
  • Ability to accept and follow verbal instruction
  • Gross Motor Function Classification System (GMFCS) at level I-II
  • Willingness to participate

You may not qualify if:

  • Other than spastic form of cerebral palsy (ataxia, athetoid or dystonic)
  • Quadriplegia
  • History of orthopaedic surgery in the last 12 months
  • History of Botulinum Toxin A application in the last 6 months
  • Severe mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LKH Graz - Department of Pediatric and Adolescent Surgery

Graz, Styria, 8036, Austria

Location

Related Publications (10)

  • Scholtes VA, Dallmeijer AJ, Rameckers EA, Verschuren O, Tempelaars E, Hensen M, Becher JG. Lower limb strength training in children with cerebral palsy--a randomized controlled trial protocol for functional strength training based on progressive resistance exercise principles. BMC Pediatr. 2008 Oct 8;8:41. doi: 10.1186/1471-2431-8-41.

    PMID: 18842125BACKGROUND

  • Faigenbaum AD, Kraemer WJ, Blimkie CJ, Jeffreys I, Micheli LJ, Nitka M, Rowland TW. Youth resistance training: updated position statement paper from the national strength and conditioning association. J Strength Cond Res. 2009 Aug;23(5 Suppl):S60-79. doi: 10.1519/JSC.0b013e31819df407.

    PMID: 19620931BACKGROUND

  • Romero-Arenas S, Martinez-Pascual M, Alcaraz PE. Impact of resistance circuit training on neuromuscular, cardiorespiratory and body composition adaptations in the elderly. Aging Dis. 2013 Oct 1;4(5):256-63. doi: 10.14336/AD.2013.0400256.

    PMID: 24124631BACKGROUND

  • Fukumoto Y, Tateuchi H, Ikezoe T, Tsukagoshi R, Akiyama H, So K, Kuroda Y, Ichihashi N. Effects of high-velocity resistance training on muscle function, muscle properties, and physical performance in individuals with hip osteoarthritis: a randomized controlled trial. Clin Rehabil. 2014 Jan;28(1):48-58. doi: 10.1177/0269215513492161. Epub 2013 Jul 3.

    PMID: 23823710BACKGROUND

  • Miller MB, Pearcey GE, Cahill F, McCarthy H, Stratton SB, Noftall JC, Buckle S, Basset FA, Sun G, Button DC. The effect of a short-term high-intensity circuit training program on work capacity, body composition, and blood profiles in sedentary obese men: a pilot study. Biomed Res Int. 2014;2014:191797. doi: 10.1155/2014/191797. Epub 2014 Feb 23.

    PMID: 24707476BACKGROUND

  • Rose SA, DeLuca PA, Davis RB 3rd, Ounpuu S, Gage JR. Kinematic and kinetic evaluation of the ankle after lengthening of the gastrocnemius fascia in children with cerebral palsy. J Pediatr Orthop. 1993 Nov-Dec;13(6):727-32. doi: 10.1097/01241398-199311000-00007.

    PMID: 8245196BACKGROUND

  • Zhao H, Ren Y, Wu YN, Liu SQ, Zhang LQ. Ultrasonic evaluations of Achilles tendon mechanical properties poststroke. J Appl Physiol (1985). 2009 Mar;106(3):843-9. doi: 10.1152/japplphysiol.91212.2008. Epub 2008 Dec 31.

    PMID: 19118156BACKGROUND

  • Williams EN, Carroll SG, Reddihough DS, Phillips BA, Galea MP. Investigation of the timed 'up & go' test in children. Dev Med Child Neurol. 2005 Aug;47(8):518-24. doi: 10.1017/s0012162205001027.

    PMID: 16108451BACKGROUND

  • Schranz C, Kruse A, Tilp M, Svehlik M. Is there a relationship between muscle-tendon properties and a variety of functional tasks in children with spastic cerebral palsy? Gait Posture. 2021 Mar;85:14-19. doi: 10.1016/j.gaitpost.2021.01.009. Epub 2021 Jan 14.

    PMID: 33487525DERIVED

  • Schranz C, Kruse A, Belohlavek T, Steinwender G, Tilp M, Pieber T, Svehlik M. Does Home-Based Progressive Resistance or High-Intensity Circuit Training Improve Strength, Function, Activity or Participation in Children With Cerebral Palsy? Arch Phys Med Rehabil. 2018 Dec;99(12):2457-2464.e4. doi: 10.1016/j.apmr.2018.06.010. Epub 2018 Jul 4.

    PMID: 30473019DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martin Svehlik, MD, PhD

    LKH-Univ.Klinikum Graz

    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
SPONSOR INVESTIGATOR
PI Title
Senior surgeon

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 18, 2014

Study Start

January 1, 2015

Primary Completion

July 14, 2017

Study Completion

July 14, 2017

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

AU(1)