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Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

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ClinicalTrials.gov Identifier: NCT03702348
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Isabel Lins Neumann, Universidade Federal de Pernambuco

Brief Summary:
Common symptoms of chikungunya fever are persistent arthritis and arthralgia, such symptoms can lead to impairment in functionality. The objective of this study is to evaluate the efficacy of a resistance exercise protocol on the functionality of individuals with chronic musculoskeletal manifestations of Chikungunya fever. Quality of life, number of painful joints, intensity of pain, number of recurrence of exacerbation and thermography are secondary outcomes that will also be evaluated. The protocol uses elastic resistance to strengthen muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks. The control group will not be submitted to the intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks the control group will perform the same protocol. The sample will be characterized and the effect size and the mean difference will be calculated. Intention-to-treat analysis and rate of adherence will also be calculated.

Condition or disease Intervention/treatment Phase
Chikungunya Fever Other: Resistance exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Experimental: Resistance exercise group
Progressive resistance exercise protocol with elastic resistance to strengthen the muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks.
Other: Resistance exercise
Protocol with 5min warm-up exercise and 8 exercises that progress in positioning and resistance based on maximum repetition test. The exercises strengthen both the lower and upper limbs and are intended to simulate activities such as sitting and standing up, climbing stairs, picking up weight ...
Other Name: Resistance exercise protocol

No Intervention: Control group
No intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks, this group will perform the same protocol as the experimental group



Primary Outcome Measures :
  1. Change in functionality through a walk test [ Time Frame: Assessed before intervention, in 6 weeks and after the 12-week intervention ]
    Performance in seconds of the 40m Fast-paced Walk Test

  2. Change in functionality through a stair climb test [ Time Frame: Assessed before intervention, in 6 weeks and after the 12-week intervention ]
    performance in seconds of the 4 step stair climb test

  3. Change in functionality through a chair stand test [ Time Frame: Assessed before intervention, in 6 weeks and after the 12-week intervention ]
    Performance in number of time the patient stands in the 30-Second Chair Stand Test

  4. Change in functionality of upper limbs [ Time Frame: Assessed before intervention, in 6 weeks and after the 12-week intervention ]
    Function of upper limb trough specific score of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire with 30 items with responses range from 1(not limited) to 5 (extremely limited) and two optional sections, responses are used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)


Secondary Outcome Measures :
  1. Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire [ Time Frame: assessed before intervention, in 6 weeks and after the 12-week intervention ]
    quality of life assesment through Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire that consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0 (maximum disability) to 100(no disability) scale

  2. Change in the intensity of pain: VAS [ Time Frame: assessed in every intervention day (twice a week for 12 weeks) ]
    number correspondent to the intensity of pain using visual analogic scale from 0(no pain) to 10 (maximum pain)

  3. Change in the number of painful joints [ Time Frame: assessed before intervention, in 6 weeks and after the 12-week intervention ]
  4. Change in the number of exacerbation recurrences [ Time Frame: assessed through the 12-week intervention period ]
  5. Change in temperature of areas of interest (joints) [ Time Frame: assessed before intervention, in 6 weeks and after the 12-week intervention ]
    assessed with thermography through index of thermic distribution seen through software FLIR Tools 5.3

  6. Change in patients global impression of change [ Time Frame: assessed before intervention, in 6 weeks and after the 12-week intervention ]
    number corresponding to answer of the Patient Global Impression of Change (PGIC) questionnaire

  7. Adverse effects [ Time Frame: Reported through study completion, an average of 1 year ]
    Unexpected effects reported by patients potentially associated with the intervention

  8. Change in muscle strength [ Time Frame: Assessed every two weeks during the 12-week intervention period ]
    Performance in the repetition maximum test (1RM) for every exercise



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Chikungunya fever for more than three months
  • Present musculoskeletal symptoms after infection (eg, arthritis or arthralgia)

Exclusion Criteria:

  • Cognitive deficit that compromises the understanding and accomplishment of the protocol (MiniMental<24);
  • Self-reported disease that contraindicates the performance of research procedures (eg, unstable angina);
  • Self-reported diagnosis of neurological disease;
  • Prior self-reported diagnosis of other inflammatory or autoimmune rheumatic diseases or fibromyalgia;
  • Pregnancy;
  • Physical impairment that prevents arrival to the research site or execution of the exercises (eg, use of walking devices);
  • Execution of other physiotherapeutic treatments during the research period;
  • Regular practice of physical exercises in other places during the period of participation in the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702348


Contacts
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Contact: Isabel Neumann +55 (81) 986481113 bel_lins_neumann@hotmail.com
Contact: Angélica Tenório tenorioangelica@yahoo.com.br

Locations
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Brazil
Clínica Escola de Fisioterapia - UFPE Recruiting
Recife, Pernambuco, Brazil, 50740-560
Contact: Joaquim de Lima Neto    +55 (81) 21267696    clinicaescola.fisioterapia@ufpe.br   
Sponsors and Collaborators
Universidade Federal de Pernambuco

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Responsible Party: Isabel Lins Neumann, Graduated and completing masters, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03702348     History of Changes
Other Study ID Numbers: U1111-1216-9761
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fever
Chikungunya Fever
Body Temperature Changes
Signs and Symptoms
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases