Effect of Acupuncture on Hemodialysis Patients

Not Applicable

Completed

• Conditions: Acupuncture Therapy; Hemodialysis Patients; Quality of Life; Activities of Daily Living
• Interventions: Other: Acupuncture; Other: Sham Acupuncture

• Registration Number: NCT05362643
• Lead Sponsor: Universidade do Porto

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-08-30
• Primary Completion: 2021-11-01
• Study Completion: 2022-02-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-30
• Last Update Submitted: 2022-04-30
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Group	Acupuncture	Experimental groups were divided into subgroup A and B and both received a total of 9 acupuncture treatments. However Acupuncture Subgroup A received 3 acupuncture sessions over 3 weeks and Acupuncture Subgroup B received 1 acupuncture session for 9 weeks. The same selection of acupuncture points were applied to both subgroups.
Sham Acupuncture Group	Sham Acupuncture	Sham Acupuncture groups were also divided into subgroup A and B and both received a total of 9 treatments. Sham Acupuncture subgroup A received 3 sessions over 3 weeks and Sham Acupuncture subgroup B received 1 session for 9 weeks. Sham Acupuncture subgroups received acupuncture on non-acupuncture points.

Primary Outcome Measures

Name	Time	Method
Performance on activities of daily living (ADL´s)	Follow up (12 weeks post-treatment).	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.
Health-Related Quality of Life	Follow up (12 weeks post-treatment).	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.

Secondary Outcome Measures

Name	Time	Method
Handgrip strength	Follow up (12 weeks post-treatment).	Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength.
Lower limbs strength	Follow up (12 weeks post-treatment).	Measured by 30 second Sit-to-Stand Test.

Trial Locations

Locations (1)

Marta Raquel Custódio Correia de Carvalho; 🇵🇹 Porto, Portugal