Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

September 25, 2019 updated by: Isabel Lins Neumann, Universidade Federal de Pernambuco

Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-560
        • Clínica Escola de Fisioterapia - UFPE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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, the longer the time in seconds, the worse the outcome. The normative values for women between 50´s and 60´s age range are 19,90 to 22,60 seconds, and for men in the same age range between 19,32 and 20,73 seconds.
Assessed before intervention, in 6 weeks and after the 12-week intervention
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, the longer the time in seconds, the worse the outcome. The normative values mean for healthy women is 10.22 seconds and healthy men is 8.72 seconds
Assessed before intervention, in 6 weeks and after the 12-week intervention
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, the higher the number of the better the outcome, the mean for women in the 60´s age range is from 11 to 17 times and for men in the same age range is from 12 to 19 times
Assessed before intervention, in 6 weeks and after the 12-week intervention
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)
Assessed before intervention, in 6 weeks and after the 12-week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
assessed before intervention, in 6 weeks and after the 12-week intervention
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)
assessed in every intervention day (twice a week for 12 weeks)
Change in the number of painful joints
Time Frame: assessed before intervention, in 6 weeks and after the 12-week intervention
assessed though a tender joints count, the higher the number the worse the outcome
assessed before intervention, in 6 weeks and after the 12-week intervention
Change in the number of exacerbation recurrences
Time Frame: assessed through the 12-week intervention period
the higher the number the worse the outcome
assessed through the 12-week intervention period
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. the higher the temperature the worse the outcome
assessed before intervention, in 6 weeks and after the 12-week intervention
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 being 1 (no change) the worst outcome and 7 (a lot better) the best outcome
assessed before intervention, in 6 weeks and after the 12-week intervention
Number of patients reporting adverse effects
Time Frame: Reported through study completion, an average of 1 year
Unexpected effects reported by patients potentially associated with the intervention such as worsening pain, swelling, stiffness or other
Reported through study completion, an average of 1 year
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, the higher the value the better the outcome
Assessed every two weeks during the 12-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1216-9761

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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