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Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

Primary Purpose

Chikungunya Fever

Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chikungunya Fever

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Escola de Fisioterapia - UFPE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance exercise group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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
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
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)

Secondary Outcome Measures

Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire
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
Change in the intensity of pain: VAS
number correspondent to the intensity of pain using visual analogic scale from 0(no pain) to 10 (maximum pain)
Change in the number of painful joints
assessed though a tender joints count, the higher the number the worse the outcome
Change in the number of exacerbation recurrences
the higher the number the worse the outcome
Change in temperature of areas of interest (joints)
assessed with thermography through index of thermic distribution seen through software FLIR Tools 5.3. the higher the temperature the worse the outcome
Change in patients global impression of change
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
Number of patients reporting adverse effects
Unexpected effects reported by patients potentially associated with the intervention such as worsening pain, swelling, stiffness or other
Change in muscle strength
Performance in the repetition maximum test (1RM) for every exercise, the higher the value the better the outcome

Full Information

First Posted
July 9, 2018
Last Updated
September 25, 2019
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT03702348
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Other Intervention Name(s)
Resistance exercise protocol
Intervention Description
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 ...
Primary Outcome Measure Information:
Title
Change in functionality through a walk test
Description
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.
Time Frame
Assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Change in functionality through a stair climb test
Description
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
Time Frame
Assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Change in functionality through a chair stand test
Description
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
Time Frame
Assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Change in functionality of upper limbs
Description
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)
Time Frame
Assessed before intervention, in 6 weeks and after the 12-week intervention
Secondary Outcome Measure Information:
Title
Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire
Description
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
Time Frame
assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Change in the intensity of pain: VAS
Description
number correspondent to the intensity of pain using visual analogic scale from 0(no pain) to 10 (maximum pain)
Time Frame
assessed in every intervention day (twice a week for 12 weeks)
Title
Change in the number of painful joints
Description
assessed though a tender joints count, the higher the number the worse the outcome
Time Frame
assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Change in the number of exacerbation recurrences
Description
the higher the number the worse the outcome
Time Frame
assessed through the 12-week intervention period
Title
Change in temperature of areas of interest (joints)
Description
assessed with thermography through index of thermic distribution seen through software FLIR Tools 5.3. the higher the temperature the worse the outcome
Time Frame
assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Change in patients global impression of change
Description
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
Time Frame
assessed before intervention, in 6 weeks and after the 12-week intervention
Title
Number of patients reporting adverse effects
Description
Unexpected effects reported by patients potentially associated with the intervention such as worsening pain, swelling, stiffness or other
Time Frame
Reported through study completion, an average of 1 year
Title
Change in muscle strength
Description
Performance in the repetition maximum test (1RM) for every exercise, the higher the value the better the outcome
Time Frame
Assessed every two weeks during the 12-week intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clínica Escola de Fisioterapia - UFPE
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil

12. IPD Sharing Statement

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Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever

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