Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

NCT ID: NCT03702348

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-11-30

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.

Conditions

Chikungunya Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance exercise

Intervention Type: OTHER

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 ...

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 ...

Intervention Type: OTHER

Other Intervention Names

Resistance exercise protocol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Isabel Lins Neumann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clínica Escola de Fisioterapia - UFPE

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

U1111-1216-9761

Identifier Type: -

Identifier Source: org_study_id