Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever
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|ClinicalTrials.gov Identifier: NCT03702348|
Recruitment Status : Unknown
Verified September 2019 by Isabel Lins Neumann, Universidade Federal de Pernambuco.
Recruitment status was: Active, not recruiting
First Posted : October 11, 2018
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chikungunya Fever||Other: Resistance exercise||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||November 2019|
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 Name: 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
- 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.
- 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
- 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
- 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)
- 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
- 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)
- 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
- Change in the number of exacerbation recurrences [ Time Frame: assessed through the 12-week intervention period ]the higher the number the worse the outcome
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702348
|Clínica Escola de Fisioterapia - UFPE|
|Recife, Pernambuco, Brazil, 50740-560|