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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Non-Acupuncture Group | No Intervention | Non-acupuncture treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lower limbs strength | Measured by 30 second Sit-to-Stand (STS-30) Test. | Baseline. |
| Lower limbs strength | Measured by 30 second Sit-to-Stand (STS-30) Test. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and clinical variables | Collected by Sociodemographic and Clinical Data Collection Form. | Baseline |
| Pre-intervention questionnaire | Participants who received acupuncture or sham acupuncture (acupuncture or sham acupuncture) answered a questionnaire about their expectations regarding the treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta RC Correia de Carvalho, M.Sc | ICBAS School of Medicine and Biomedical Sciences - Oporto University, Portugal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marta Raquel Custódio Correia de Carvalho | Porto | 4050-313 | Portugal |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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). |
|
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). |
| After Treatment: 3 weeks after baseline assessment (subgroup A). |
| Lower limbs strength | Measured by 30 second Sit-to-Stand (STS-30) Test. | After Treatment: 9 weeks after baseline assessment (subgroup B). |
| Lower limbs strength | Measured by 30 second Sit-to-Stand Test. | 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. | 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. | 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. | 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. | Follow up (12 weeks post-treatment). |
| Baseline |
| 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). |
| 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). |
| Blood analytical data | Blood Tests | Baseline. |
| Blood analytical data | Blood Tests | After Treatment: 3 weeks after baseline assessment (subgroup A). |
| Blood analytical data | Blood Tests | After Treatment: 9 weeks after baseline assessment (subgroup B). |
| Blood analytical data | Blood Tests | Follow up (12 weeks post-treatment). |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |