Intradialytic Exercises During Hemodialysis

NCT02908594 | Completed DMC

• 1 other identifier: CardinalTH
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim. To investigate the effect of an intradialytic aerobic and resistance cycling exercise program (IARCEP) on depression, fatigue, and quality of life (QOL) in end-stage renal disease (ESRD) patients receiving haemodialysis, and further determine the effect of mediation through self-efficacy and resilience in patients receiving the IARCEP. Background. Depression and fatigue are common in ESRD patients undergoing haemodialysis, which negatively affects their QOL. Exercise can mitigate this effect. Patient's self-efficacy and resilience may be crucial mediators in exercise. Design. This study was a randomised controlled trial. Method. Seventy-six participants were randomly assigned to either a control or exercise group. Both groups received routine care; whereas the exercise group participated the 3- months IARCEP. Data were collected at baseline, the first, second, and third months, over a 14 months in 2013-2014.

Conditions

Kidney Failure, Chronic

Keywords

Nursing; ESRD; hemodialysis; intradialytic exercise; depression; fatigue; Quality Of Life; self-efficacy; resilience

Outcome Measures

Primary Outcomes (1)

• Generalized estimating equation model on the effects of depression, fatigue, and health-related quality of life

  Data were collected over a 14 months in 2013-2014.

Secondary Outcomes (3)

• Differences-in-differences on the effects of the depression, fatigue, quality of life in exercise group

  Data were collected over a 14 months in 2013-2014.

• Generalized estimating equation on the mediated effects of self-efficacy and resilience with exercise on outcomes

  Data were collected over a 14 months in 2013-2014.

• The mediated effects on relationships between exercise and outcomes

  Data were collected over a 14 months in 2013-2014.

Study Arms (2)

exercise group

EXPERIMENTAL

Using the Medical Exercise Peddler 3000, Medi-Bike, Taiwan as an exercise tool. Exercise group received routine care and 3- months exercise. The exercise was performed during the first 2 hr of each haemodialysis session (30 min per session, 3 sessions per week for 3 months).

Device: Medical Exercise Peddler 3000, Medi-Bike, Taiwan

control group

NO INTERVENTION

The control group received routine care

Interventions

Medical Exercise Peddler 3000, Medi-Bike, Taiwan DEVICE

A horizontal electromagnetic cycle ergometer (Medical Exercise Peddler 3000, Medi-Bike, Taiwan) was used for the exercise program. The cycling equipment includes the resistance of 6 Levels, from Level 1 the lightest to Level 6 the heaviest. Other indicators examined are RPM (rotary per minute), DICT (The distance for this exercise), TIME (The time of exercise). This is the simplest way to use this Motion Exercise Machine. Press the "ST / SP (Start/ Stop)" button to start an exercise program for 30 minutes.

exercise group

Eligibility Criteria

• Age: 24 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 20 years
• provided consent to participate in this study
• received haemodialysis 3 times per week for least 3 months
• missed no more than two dialysis sessions in the previous month
• had an adequate dialysis, counted by Kt / V over 1.2
• no lower dialysis graft, basic comprehension and communication in Mandarin or Taiwanese
• on positive response to any of the supplementary questions in the Physical Activity Readiness Questionnaire (PAR-Q).

You may not qualify if:

• is currently infection or inflammation, autoimmunity disorders, cerebrovascular accidents in the previous 6 months
• severe muscle weakness or interfering skeletal deformities on lower limbs
• history of repeated episodes of hypoglycaemia, cardiopulmonary contraindications to resistance exercise (e.g., myocardial infarction, active angina, and uncompensated congestive heart failure in the previous 6 months)
• lower limb amputation
• history of participating regularly in exercise programs over 3 months.

Sponsors & Collaborators

• Cardinal Tien Hospital: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Depression; Fatigue

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Signs and Symptoms

Study Officials

• Mei-Ling YEH

  Professor, Graduate Institute of Integration of Traditional Chinese Medicine with Western Nursing, National Taipei University of Nursing & Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institutional Review Board

Study Record Dates

• First Submitted: September 10, 2016
• First Posted: September 21, 2016
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: May 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-09