Effect of Acupuncture on Hemodialysis Patients

NCT05362643 | Completed

• 1 other identifier: UPorto_MCC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic Kidney Disease; Hemodialysis; Acupuncture; Activities of daily living; Health-Related Quality of Life.

Outcome Measures

Primary Outcomes (8)

• 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.

• 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).

• 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).

• 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).

• 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.

• 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).

• 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).

• 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 Outcomes (8)

• Lower limbs strength

  Baseline.

• Lower limbs strength

  After Treatment: 3 weeks after baseline assessment (subgroup A).

• Lower limbs strength

  After Treatment: 9 weeks after baseline assessment (subgroup B).

• Lower limbs strength

  Follow up (12 weeks post-treatment).

• Handgrip strength

  Baseline

Other Outcomes (8)

• Demographic and clinical variables

  Baseline

• Pre-intervention questionnaire

  Baseline

• Pos-intervention questionnaire

  After Treatment: 3 weeks after baseline assessment (subgroup A).

Study Arms (3)

Acupuncture Group

EXPERIMENTAL

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.

Other: Acupuncture

Sham Acupuncture Group

PLACEBO COMPARATOR

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.

Other: Sham Acupuncture

Non-Acupuncture Group

NO INTERVENTION

Non-acupuncture treatment.

Interventions

Acupuncture OTHER

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).

Acupuncture Group

Sham Acupuncture OTHER

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).

Sham Acupuncture Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Marta Raquel Custódio Correia de Carvalho

Porto, 4050-313, Portugal

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Marta RC Correia de Carvalho, M.Sc

  ICBAS School of Medicine and Biomedical Sciences - Oporto University, Portugal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: August 30, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)