Clinical trial NCT05362643: Effect of Acupuncture on Hemodialysis Patients
Official title: Effect of Acupuncture on Functional Capacity and Health-Related Quality of Life of Hemodialysis Patients: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance on activities of daily living (ADL´s)
timeFrame: Baseline.
measure: Performance on activities of daily living (ADL´s)
timeFrame: After Treatment: 3 weeks after baseline assessment (subgroup A).
measure: Performance on activities of daily living (ADL´s)
timeFrame: After Treatment: 9 weeks after baseline assessment (subgroup B).
measure: Performance on activities of daily living (ADL´s)
timeFrame: Follow up (12 weeks post-treatment).
measure: Health-Related Quality of Life
timeFrame: Baseline.
measure: Health-Related Quality of Life
timeFrame: After Treatment: 3 weeks after baseline assessment (subgroup A).
measure: Health-Related Quality of Life
timeFrame: After Treatment: 9 weeks after baseline assessment (subgroup B).
measure: Health-Related Quality of Life
timeFrame: Follow up (12 weeks post-treatment).
Secondary outcomes:
measure: Lower limbs strength
timeFrame: Baseline.
measure: Lower limbs strength
timeFrame: After Treatment: 3 weeks after baseline assessment (subgroup A).
measure: Lower limbs strength
timeFrame: After Treatment: 9 weeks after baseline assessment (subgroup B).
measure: Lower limbs strength
timeFrame: Follow up (12 weeks post-treatment).
measure: Handgrip strength
timeFrame: Baseline
measure: Handgrip strength
timeFrame: After Treatment: 3 weeks after baseline assessment (subgroup A).
measure: Handgrip strength
timeFrame: After Treatment: 9 weeks after baseline assessment (subgroup B).
measure: Handgrip strength
timeFrame: Follow up (12 weeks post-treatment).
Other outcomes:
measure: Demographic and clinical variables
timeFrame: Baseline
measure: Pre-intervention questionnaire
timeFrame: Baseline
measure: Pos-intervention questionnaire
timeFrame: After Treatment: 3 weeks after baseline assessment (subgroup A).
measure: Pos-intervention questionnaire
timeFrame: After Treatment: 9 weeks after baseline assessment (subgroup B).
measure: Blood analytical data
timeFrame: Baseline.
measure: Blood analytical data
timeFrame: After Treatment: 3 weeks after baseline assessment (subgroup A).
measure: Blood analytical data
timeFrame: After Treatment: 9 weeks after baseline assessment (subgroup B).
measure: Blood analytical data
timeFrame: Follow up (12 weeks post-treatment).
Locations:
city: Porto
country: Portugal
facility: Marta Raquel Custódio Correia de Carvalho
Study officials:
affiliation: ICBAS School of Medicine and Biomedical Sciences - Oporto University, Portugal
name: Marta RC Correia de Carvalho, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: