Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

NCT03702348 | Unknown Early Phase 1

• 1 other identifier: U1111-1216-9761
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in functionality through a walk test

  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

  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

  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

  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 Outcomes (8)

• Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire

  assessed before intervention, in 6 weeks and after the 12-week intervention

• Change in the intensity of pain: VAS

  assessed in every intervention day (twice a week for 12 weeks)

• Change in the number of painful joints

  assessed before intervention, in 6 weeks and after the 12-week intervention

• Change in the number of exacerbation recurrences

  assessed through the 12-week intervention period

• Change in temperature of areas of interest (joints)

  assessed before intervention, in 6 weeks and after the 12-week intervention

Study Arms (2)

Resistance exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Resistance exercise 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 ...

Also known as: Resistance exercise protocol

Resistance exercise group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Clínica Escola de Fisioterapia - UFPE

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: October 11, 2018
• Study Start: July 23, 2018
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

BR (1)