Effect of Acupuncture on Hemodialysis Patients

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362643
• Other study ID #: UPorto_MCC
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

End-stage renal disease (ESRD) patients undergoing hemodialysis (HD) experience multiple physical and emotional problems, undergo a complex and demanding treatment regimen, face a disruptive chronic disease with a significant decrease in functional capacity and a high impact on their HRQoL. Traditional Chinese Medicine (TCM) has been progressively more accepted as an effective therapeutic approach. The fundamental questions guiding our entire research project were: What is the effect of TCM therapeutic strategies in the improvement of symptoms resulting from renal replacement therapy, in ESRD patients undergoing HD? Does acupuncture have a positive effect on FC and HRQoL of hemodialysis patient? If so, are the results maintained over the long term? And what is the effectiveness of short-term intensive interventions when compared to less frequent and prolonged interventions over time? Is it possible to integrate acupuncture into the dialysis care routine? Based on previous research questions and the complexity of CKD, the objectives of our study were: 1) to assess the effect of acupuncture on FC and HRQoL of ESRD patients undergoing hemodialysis; 2) evaluate the specific effects of acupuncture as compared to sham; 3) evaluate short and long term effects of acupuncture; 4) determine the difference between short-term intensive and ongoing but less-frequent acupuncture treatments; 5) to assess the feasibility of integrating acupuncture on dialysis care.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Activities of Daily Living
• Acupuncture Therapy
• Hemodialysis Patients
• Quality of Life

Intervention

Other:
• Acupuncture
Manual acupuncture on acupoint Tai Xi(KI3), bilateral;Sanyinjiao (SP6), bilateral; Zusanli (ST36), bilateral; Shenmen (HT7) unilateral, in the arm without arteriovenous fistula;Guan Yuan (CV4), unilateral, attempt to achieve De qi sensation. After generating needling sensation, needles were manipulated for one minute, every ten minutes during needle retention (20 minutes), using Sterilized stainless steel needle (0,25x25mm; Tewa, asia-med GmbH).
• Sham Acupuncture
Manual acupuncture performed as superficial needling (5mm depth) on non-acupuncture points without an attempt to achieve De qi sensation and without stimulation, lasting 20 minutes, using Sterilized stainless steel needle (0,25x25mm; Tewa, asia-med GmbH).

Locations

Country	Name	City	State
Portugal	Marta Raquel Custódio Correia de Carvalho	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

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).