Clinical trial NCT03702348: Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever
Official title: Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Chikungunya Fever
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in functionality through a walk test
timeFrame: Assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Change in functionality through a stair climb test
timeFrame: Assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Change in functionality through a chair stand test
timeFrame: Assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Change in functionality of upper limbs
timeFrame: Assessed before intervention, in 6 weeks and after the 12-week intervention
Secondary outcomes:
measure: Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire
timeFrame: assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Change in the intensity of pain: VAS
timeFrame: assessed in every intervention day (twice a week for 12 weeks)
measure: Change in the number of painful joints
timeFrame: assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Change in the number of exacerbation recurrences
timeFrame: assessed through the 12-week intervention period
measure: Change in temperature of areas of interest (joints)
timeFrame: assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Change in patients global impression of change
timeFrame: assessed before intervention, in 6 weeks and after the 12-week intervention
measure: Number of patients reporting adverse effects
timeFrame: Reported through study completion, an average of 1 year
measure: Change in muscle strength
timeFrame: Assessed every two weeks during the 12-week intervention period
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Clínica Escola de Fisioterapia - UFPE
state: Pernambuco
Study officials:
References: