An interventional study of Exercise in Peritoneal Dialysis, Exercise and Gastrointestinal Function, sponsored by Sichuan Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Sichuan Academy of Medical Sciences · Not applicable, Interventional, and Treatment
This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.
Maintaining gastrointestinal health is paramount for individuals on peritoneal dialysis, yet it frequently goes unnoticed within the broader scope of their health management. The effectiveness of dialysis treatments, along with aspects such as nutrient uptake and life quality, can be adversely affected by gastrointestinal disturbances. The volume of fluid within the peritoneal space, medications associated with dialysis, and the procedure of dialysis itself are all known to play roles in modulating gastrointestinal health.
The role of physical activity in enhancing gastrointestinal wellness among those with chronic conditions has gained acknowledgment over time. Customized exercise regimes have been shown to markedly better gastrointestinal symptoms, the efficiency of nutrient absorption, and overall life satisfaction among these patients. Notably, the specific influence of exercise on the gastrointestinal functions of individuals undergoing peritoneal dialysis has yet to be explored.
This investigation aims to assess the effects of exercise on the gastrointestinal health of peritoneal dialysis patients. Participants will be divided equally into an exercise group and a control group, following a randomized selection process. After collecting data throughout a four-month period, an analysis will be conducted to ascertain the benefits of physical activity for enhancing the gastrointestinal function of those on peritoneal dialysis. The outcomes of this study are anticipated to guide clinicians in recommending strategies to improve gastrointestinal health in this patient population.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 132 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Presence of severe cardiovascular diseases, including but not limited to:
Severe pulmonary diseases, including but not limited to:
The exercise intervention group will receive guidance for exercises and participate in remote exercise sessions monitored.
Behavioral: Exercise
The control group will not receive exercise intervention.
* Frequency: Exercise sessions will occur no less than three times per week. * Intensity: The intensity will be based on a rating of perceived exertion score ranging from 12 to 16 on a scale of 6 to 20. * Exercise duration: Each exercise session will last approximately 30 minutes. * Exercise Type:The exercise regimen will include aerobic exercise, resistance exercise, and flexibility training.
Change in GIQLI
The Gastrointestinal Quality of Life Index is a 36-item questionnaire assessing the impact of gastrointestinal symptoms and diseases on daily life. The GIQLI includes five domains: gastrointestinal symptoms (19 items), emotional status (5 items), physical function (7 items), social function (4 items), and medical inconvenience (1 item). Each item is scored from 0 to 4, with a total score ranging from 0 to 144. Higher scores indicate better quality of life.
Time frame: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in GSRS
Gastrointestinal Symptom Rating Scale (GSRS)consists of 15 questions aimed at assessing the impact of upper and lower gastrointestinal symptoms. It includes five dimensions (symptoms of gastroesophageal reflux, diarrhea, constipation, abdominal pain, and indigestion), with each question scored from 0 (no discomfort) to 6 (very severe discomfort). A GSRS score of ≥1 defines the presence of gastrointestinal symptoms A higher score indicates more severe gastrointestinal symptoms.
Time frame: Patients are also required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in PAC-SYM
Patient Assessment of Constipation Symptom (PAC-SYM) comprises 12 questions designed to evaluate the impact of upper and lower gastrointestinal symptoms. It assesses five dimensions, including symptoms of gastroesophageal reflux, diarrhea, constipation, abdominal pain, and indigestion. Each question is scored from 0 (no discomfort) to 6 (very severe discomfort). A GSRS score of ≥1 indicates the presence of gastrointestinal symptoms, with higher scores indicating more severe symptoms.
Time frame: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in 6-MWT
The 6-Minute Walk Test (6-MWT) is conducted along a 10-meter path marked with two turning points. Patients are instructed to walk back and forth along the path for 6 minutes, and the total walking distance is measured. The test duration is monitored using a stopwatch. Based on the walking distance achieved, patients' heart failure severity is categorized as follows: \<150m indicates severe heart failure; 150-425m indicates moderate heart failure; 426-550m indicates mild heart failure.
Time frame: Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.
Change in SGA
The Subjective Global Assessment (SGA) is a tool utilized to assess the nutritional status of patients. It involves a comprehensive evaluation of various factors such as weight change, dietary intake, gastrointestinal symptoms, and functional capacity.
Time frame: Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.
Change in measured Gastrointestinal Hormones
The assessment includes the measurement of Ghrelin, Pancreatic polypeptide, and peotideYY, which are gastrointestinal hormones involved in regulating appetite and digestion.
Time frame: Blood samples will be collected at the baseline and and 3 months the intervention.
Plan to share: No
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Sichuan Academy of Medical Sciences