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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
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).
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).
Marta Raquel Custódio Correia de Carvalho
Porto, Portugal
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
60
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow up (12 weeks post-treatment).
Lower limbs strength
Measured by 30 second Sit-to-Stand (STS-30) Test.
Time frame: Baseline.
Lower limbs strength
Measured by 30 second Sit-to-Stand (STS-30) Test.
Time frame: After Treatment: 3 weeks after baseline assessment (subgroup A).
Lower limbs strength
Measured by 30 second Sit-to-Stand (STS-30) Test.
Time frame: After Treatment: 9 weeks after baseline assessment (subgroup B).
Lower limbs strength
Measured by 30 second Sit-to-Stand Test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow up (12 weeks post-treatment).