Acupuncture TherapyNCT05362643
Effect of Acupuncture on Hemodialysis Patients
A study testing Acupuncture in people with Acupuncture Therapy and Hemodialysis Patients, run by Universidade do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acupuncture Therapy, Hemodialysis Patients, Quality of Life
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Aug 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Randomized Controlled Trial.
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.
Read the 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.
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Chronic Kidney Disease, Hemodialysis, Acupuncture, Activities of daily living, Health-Related Quality of Life.
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 AcupunctureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Acupuncture |
| Non-Acupuncture Group | No intervention | Non-acupuncture treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up (12 weeks post-treatment).
Secondary outcomes (8)
Lower limbs strength
Measured by 30 second Sit-to-Stand (STS-30) Test.
Measured: Baseline.
Lower limbs strength
Measured by 30 second Sit-to-Stand (STS-30) Test.
Measured: After Treatment: 3 weeks after baseline assessment (subgroup A).
Lower limbs strength
Measured by 30 second Sit-to-Stand (STS-30) Test.
Measured: After Treatment: 9 weeks after baseline assessment (subgroup B).
Lower limbs strength
Measured by 30 second Sit-to-Stand Test.
Measured: Follow up (12 weeks post-treatment).
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.
Measured: Baseline
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.
Measured: After Treatment: 3 weeks after baseline assessment (subgroup A).
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.
Measured: After Treatment: 9 weeks after baseline assessment (subgroup B).
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.
Measured: Follow up (12 weeks post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start30 Aug 2021
- Primary completion1 Nov 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Raquel Custódio Correia de Carvalho, Universidade do Porto
- Investigators
- Marta RC Correia de Carvalho, M.Sc, Principal investigator, ICBAS School of Medicine and Biomedical Sciences - Oporto University, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362643
- Sponsor's protocol ID
- UPorto_MCC
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05362643
- Acronym / sponsor ID
- UPorto_MCC
- Keywords
- Chronic Kidney Disease, Hemodialysis, Acupuncture, Activities of daily living, Health-Related Quality of Life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Other: AcupunctureExperimental 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 | Placebo comparator | Other: Sham AcupunctureSham 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. |
| Non-Acupuncture Group | No intervention | –Non-acupuncture treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureManual 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). | Other | Acupuncture Group |
| Sham AcupunctureManual 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). | Other | Sham Acupuncture Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
Lower limbs strength
Time frame: Baseline.
Lower limbs strength
Time frame: After Treatment: 3 weeks after baseline assessment (subgroup A).
Lower limbs strength
Time frame: After Treatment: 9 weeks after baseline assessment (subgroup B).
Lower limbs strength
Time frame: Follow up (12 weeks post-treatment).
Handgrip strength
Time frame: Baseline
Handgrip strength
Time frame: After Treatment: 3 weeks after baseline assessment (subgroup A).
Handgrip strength
Time frame: After Treatment: 9 weeks after baseline assessment (subgroup B).
Handgrip strength
Time frame: Follow up (12 weeks post-treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta RC Correia de Carvalho, M.Sc principal investigator
ICBAS School of Medicine and Biomedical Sciences - Oporto University, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture Therapy and Hemodialysis Patients, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on activities of daily living (ADL´s) (time frame: Baseline.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.