Quality of Life Clinical Trial
Official title:
Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Randomized Controlled Trial.
Verified date | April 2022 |
Source | Universidade do Porto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed randomized controlled trial (RCT) evaluated the effect of acupuncture treatment on the functional capacity (FC) and health-related quality of life (HRQoL) in stage 5 Chronic Kidney Disease (CKD) patients receiving maintenance dialysis. A total of 60 end-stage renal disease (ESRD) patients undergoing hemodialysis (HD) from a dialysis centre (Portugal), were randomly assigned to acupuncture, sham and control group.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 1, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male and female patients, age 18 years or older, receiving regular hemodialysis (HD) treatment for more than 3 months, 3-times a week session, 4h per session, with medically stable condition. Exclusion Criteria: - Patients that refuse to participate in the study, who have a clinical indication that prevents their participation in the study and patients with other comorbidities as poorly controlled malignant hypertension, unstable angina, uncontrolled diabetes mellitus, cerebrovascular failure with recurrent syncope, uncontrolled heart failure, severe mental illness or cognitive impairment will be excluded. Other conditions such as inability to practice physical exercise, have had acupuncture treatment in the past two weeks, known hypersensitivity reaction and/or other side effects after acupuncture treatment, inability to cooperate with the procedures inherent to the application of the procedure, will be also excluded from study. |
Country | Name | City | State |
---|---|---|---|
Portugal | Marta Raquel Custódio Correia de Carvalho | Porto |
Lead Sponsor | Collaborator |
---|---|
Universidade do Porto |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic and clinical variables | Collected by Sociodemographic and Clinical Data Collection Form. | Baseline | |
Other | Pre-intervention questionnaire | Participants who received acupuncture or sham acupuncture (acupuncture or sham acupuncture) answered a questionnaire about their expectations regarding the treatment. | Baseline | |
Other | Pos-intervention questionnaire | Participants who received acupuncture (acupuncture and sham acupuncture groups) answered a questionnaire to assess the degree of discomfort felt in the acupuncture treatment, the concealment of the treatment, the perception of the results and the interference of the acupuncture treatment in the routine of hemodialysis. | After Treatment: 3 weeks after baseline assessment (subgroup A). | |
Other | Pos-intervention questionnaire | Participants who received acupuncture (acupuncture and sham acupuncture groups) answered a questionnaire to assess the degree of discomfort felt in the acupuncture treatment, the concealment of the treatment, the perception of the results and the interference of the acupuncture treatment in the routine of hemodialysis. | After Treatment: 9 weeks after baseline assessment (subgroup B). | |
Other | Blood analytical data | Blood Tests | Baseline. | |
Other | Blood analytical data | Blood Tests | After Treatment: 3 weeks after baseline assessment (subgroup A). | |
Other | Blood analytical data | Blood Tests | After Treatment: 9 weeks after baseline assessment (subgroup B). | |
Other | Blood analytical data | Blood Tests | Follow up (12 weeks post-treatment). | |
Primary | Performance on activities of daily living (ADL´s) | Change in functional capacity (FC) and performance on ADL´s were measured by 6-Minute Walk Test (6MWT).
The 6MWT is a practical, simple, self-paced walking test that assesses the submaximal level of functional exercise capacity. Changes in the 6 minute walk distance will be used to evaluate the efficacy of therapeutic interventions. |
Baseline. | |
Primary | Performance on activities of daily living (ADL´s) | Change in functional capacity (FC) and performance on ADL´s were measured by 6-Minute Walk Test (6MWT).
The 6MWT is a practical, simple, self-paced walking test that assesses the submaximal level of functional exercise capacity. Changes in the 6 minute walk distance will be used to evaluate the efficacy of therapeutic interventions. |
After Treatment: 3 weeks after baseline assessment (subgroup A). | |
Primary | Performance on activities of daily living (ADL´s) | Change in functional capacity (FC) and performance on ADL´s were measured by 6-Minute Walk Test (6MWT).
The 6MWT is a practical, simple, self-paced walking test that assesses the submaximal level of functional exercise capacity. Changes in the 6 minute walk distance will be used to evaluate the efficacy of therapeutic interventions. |
After Treatment: 9 weeks after baseline assessment (subgroup B). | |
Primary | Performance on activities of daily living (ADL´s) | Change in functional capacity (FC) and performance on ADL´s were measured by 6-Minute Walk Test (6MWT).
The 6MWT is a practical, simple, self-paced walking test that assesses the submaximal level of functional exercise capacity. Changes in the 6 minute walk distance will be used to evaluate the efficacy of therapeutic interventions. |
Follow up (12 weeks post-treatment). | |
Primary | Health-Related Quality of Life | Assessed by Kidney Disease Quality of Life- Short Form (KDQOL-SFTM 1. 3). The KDQOL-SF contains eight generic subscales that assess various aspects of health-related quality of life (HRQOL) and has been widely used in CKD. | Baseline. | |
Primary | Health-Related Quality of Life | Assessed by Kidney Disease Quality of Life- Short Form (KDQOL-SFTM 1. 3). The KDQOL-SF contains eight generic subscales that assess various aspects of health-related quality of life (HRQOL) and has been widely used in CKD. | After Treatment: 3 weeks after baseline assessment (subgroup A). | |
Primary | Health-Related Quality of Life | Assessed by Kidney Disease Quality of Life- Short Form (KDQOL-SFTM 1. 3). The KDQOL-SF contains eight generic subscales that assess various aspects of health-related quality of life (HRQOL) and has been widely used in CKD. | After Treatment: 9 weeks after baseline assessment (subgroup B). | |
Primary | Health-Related Quality of Life | Assessed by Kidney Disease Quality of Life- Short Form (KDQOL-SFTM 1. 3). The KDQOL-SF contains eight generic subscales that assess various aspects of health-related quality of life (HRQOL) and has been widely used in CKD. | Follow up (12 weeks post-treatment). | |
Secondary | Lower limbs strength | Measured by 30 second Sit-to-Stand (STS-30) Test. | Baseline. | |
Secondary | Lower limbs strength | Measured by 30 second Sit-to-Stand (STS-30) Test. | After Treatment: 3 weeks after baseline assessment (subgroup A). | |
Secondary | Lower limbs strength | Measured by 30 second Sit-to-Stand (STS-30) Test. | After Treatment: 9 weeks after baseline assessment (subgroup B). | |
Secondary | Lower limbs strength | Measured by 30 second Sit-to-Stand Test. | Follow up (12 weeks post-treatment). | |
Secondary | Handgrip strength | Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength. | Baseline | |
Secondary | Handgrip strength | Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength. | After Treatment: 3 weeks after baseline assessment (subgroup A). | |
Secondary | Handgrip strength | Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength. | After Treatment: 9 weeks after baseline assessment (subgroup B). | |
Secondary | Handgrip strength | Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength. | Follow up (12 weeks post-treatment). |
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