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Completed

NCT Number: NCT05362643

Effect of Acupuncture on Hemodialysis Patients

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.

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Key information

Conditions

Acupuncture Therapy Activities of Daily Living Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Patients Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marta Raquel Custódio Correia de Carvalho

Porto, 4050-313, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. Performance on activities of daily living (ADL´s)

    Time frame: Baseline.

    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.

  2. Performance on activities of daily living (ADL´s)

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

    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.

  3. Performance on activities of daily living (ADL´s)

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

    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.

  4. Performance on activities of daily living (ADL´s)

    Time frame: 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.

  5. Health-Related Quality of Life

    Time frame: Baseline.

    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.

  6. Health-Related Quality of Life

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

    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.

  7. Health-Related Quality of Life

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

    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.

  8. Health-Related Quality of Life

    Time frame: 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 outcomes

  1. Lower limbs strength

    Time frame: Baseline.

    Measured by 30 second Sit-to-Stand (STS-30) Test.

  2. Lower limbs strength

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

    Measured by 30 second Sit-to-Stand (STS-30) Test.

  3. Lower limbs strength

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

    Measured by 30 second Sit-to-Stand (STS-30) Test.

  4. Lower limbs strength

    Time frame: Follow up (12 weeks post-treatment).

    Measured by 30 second Sit-to-Stand Test.

  5. Handgrip strength

    Time frame: Baseline

    Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength.

  6. Handgrip strength

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

    Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength.

  7. Handgrip strength

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

    Measured by Hand Grip Strength (HGS) Test, using a digital dynamometer. HGS test is commonly used as an indicator of overall muscle strength.

  8. Handgrip strength

    Time frame: 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.

Other outcomes

  1. Demographic and clinical variables

    Time frame: Baseline

    Collected by Sociodemographic and Clinical Data Collection Form.

  2. Pre-intervention questionnaire

    Time frame: Baseline

    Participants who received acupuncture or sham acupuncture (acupuncture or sham acupuncture) answered a questionnaire about their expectations regarding the treatment.

  3. Pos-intervention questionnaire

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

    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.

  4. Pos-intervention questionnaire

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

    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.

  5. Blood analytical data

    Time frame: Baseline.

    Blood Tests

  6. Blood analytical data

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

    Blood Tests

  7. Blood analytical data

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

    Blood Tests

  8. Blood analytical data

    Time frame: Follow up (12 weeks post-treatment).

    Blood Tests

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Randomized Controlled Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 5, 2022
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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