NCT03431636

Brief Summary

Para-athletes are submitted and intense efforts in training and competitions that often overlap in days and weeks. In this sense, and in the search for better brands and indexes, it is necessary to use recovery methods that allow less late muscle pain and better physical performance. Recovery methods are widely used in athletes of various modalities, however there are no studies that point out their effects on para-athletes. This highlights the need for studies on this topic. Paragliding athletes, who train at the Londrina Yacht Club, Londrina Canoeing and Rowing School, who present paraplegia after spinal cord injury, with motor level T10 or lower, without any problem of thermoregulation will participate in the study. All were male and female, with no complaints of musculoskeletal pain or history of upper limb muscle injuries in the last six months and with the same demand for training and competitions. Initially an evaluation will be performed where 1RM, VO2 max, pain, spasticity, body temperature, heart rate variability and electromyographic signal of the involved muscles will be tested. After three days they will be induced to fatigue through a protocol in the traction exercise and immediately directed to one of the 3 intervention groups: ice pack, immersion in cold water or rest. The same baseline evaluations will be repeated after 24, 48 and 72 hours. It is expected that the group submitted to immersion in cold water presents better parameters for pain and sports performance.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable pain

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

December 18, 2017

Last Update Submit

January 23, 2020

Conditions

Keywords

sports for people with disabilitiesimmersion therapycryotherapyphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • evolution of muscular pain

    late muscle pain will be assessed at various times to detect changes caused by fatigue will be analyzed through the threshold of pressure pain, in view of the induction of pain caused to the study, the pain will be monitored at various times

    pre, immediately after, after 24, 48 and 72 hours

Secondary Outcomes (4)

  • oxygen consumption

    pre, immediately after, after 24, 48 and 72 hours

  • spasticity

    pre, immediately after, after 24, 48 and 72 hours

  • muscle recruitment

    pre, immediately after, after 24, 48 and 72 hours

  • heart rate variability

    pre, immediately after, after 24, 48 and 72 hours

Study Arms (3)

Immersion in cold water

EXPERIMENTAL

The athlete will remain submerged in a "Cryo Control - Ice Bath Systems®" bathtub, which allows filtration and maintenance of constant water temperature, and shoulder blade water (Getto and Golden, 2013) for 15 minutes in the 15 degrees Celsius (Machado et al, 2016).

Other: immersion

Ice pack

ACTIVE COMPARATOR

The athlete will remain for 20 minutes with plastic packets of 500 grams of ice each, in the region of the evaluated muscles.

Other: ice pack

Control

SHAM COMPARATOR

Group in which the athlete will be instructed to remain seated in a comfortable position, at rest, for 20 minutes.

Other: rest

Interventions

cold water immersion

Immersion in cold water

ice packs through the body

Ice pack
restOTHER

seated rest

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • paraplegia after spinal cord injury, with motor level T10 or lower, without any problem of thermoregulation
  • athletes of the modality paracanoagem, that train in the Yacht Club of Londrina, in the School of canoagem and rowing of Londrina

You may not qualify if:

  • cold allergies
  • upper limb surgery in the last six months
  • scarring or skin lesions
  • peripheral vascular perfusion abnormalities
  • viral conditions (such as colds or flu)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Price MJ. Thermoregulation during exercise in individuals with spinal cord injuries. Sports Med. 2006;36(10):863-79. doi: 10.2165/00007256-200636100-00005.

    PMID: 17004849BACKGROUND
  • Ihsan M, Watson G, Abbiss CR. What are the Physiological Mechanisms for Post-Exercise Cold Water Immersion in the Recovery from Prolonged Endurance and Intermittent Exercise? Sports Med. 2016 Aug;46(8):1095-109. doi: 10.1007/s40279-016-0483-3.

    PMID: 26888646BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

ImmersionRE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Christiane Macedo

    State University of Londrina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
first investigator

Study Record Dates

First Submitted

December 18, 2017

First Posted

February 13, 2018

Study Start

July 25, 2020

Primary Completion

October 20, 2020

Study Completion

December 20, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share