The Effects of a Nurse-led Case Management Programme on Home Exercise Training for Haemodialysis Patients

NCT02075879 | Completed DMC

• 1 other identifier: HSEARS20121105002
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine the effects of a nurse-led case management programme on home exercise training for haemodialysis patients. We hypothesised that: a. There is no significant difference in physical functioning between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. b. There is no difference in depression between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. c. There is no difference in quality of life and health perception between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. d. There is no difference in physical activity levels between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. e. There is no difference in perceived benefits and barriers of exercise between participants receiving the nurse-led home exercise training programme and those receiving the comparison care. The study was a randomized controlled trial conducted in two haemodialysis units of two tertiary hospitals in Nanjing, China. Participants were randomly assigned to either study group or comparison group. Participants in both groups received the in-center exercise training (20 minutes) before haemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was focused on flexibility and strengthening exercise. Patients were encouraged to have cardiovascular exercises at home which will improve their cardiovascular conditions and endurance. The list of cardiovascular exercise included brisk walking, bicycling, jogging. Participants in the study group were instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the study group patients weekly for six weeks and biweekly for another six weeks. Participants in the comparison group only participated in the in-center exercise training. The comparison group patients received usual care from the nurse without the interviews and mutual goals developed.

Conditions

Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in walking speed on the 10-meter walking test at week 6 and change from baseline in walking speed on 10-meter walking test at week 12

  Baseline, Week 6, and Week 12

Secondary Outcomes (6)

• Change from baseline in time in completing the 10-repetition sit-to-stand test (10-STS) at week 6, and change from baseline in time in completing 10-STS at week 12

  Baseline, Week 6, and Week 12

• Change from baseline in perceived exercise benefits and barriers on the Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS) at week 6 and change from baseline in the DPEBBS score at week 12

  Baseline, Week 6, and Week 12

• Change from baseline in health-related quality of life on the Kidney Disease Quality of Life Questionnaire (KDQOL-36) at week 6, and change from baseline in KDQOL-36 score at week 12

  Baseline, Week 6, and Week 12

• Change from baseline in depressive symptoms on the Beck Depression Inventory (BDI) at week 6, and change from baseline in BDI score at week 12

  Baseline, Week 6, and Week 12

• Change from baseline in self-perceived health in the first item in the Kidney Disease Quality of Life Questionnaire at week 6, and change from baseline in self-perceived health score at week 12

  Baseline, Week 6, and Week 12

Study Arms (2)

Nurse-led interviewing

EXPERIMENTAL

Participants in experimental arm received the in-center exercise training (20 minutes) before hemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. They were additionally instructed to start walking or brisk walking at low duration and gradually progress to a maximum of 30 minutes daily per week. To facilitate exercise progression, the nurse case managers discussed exercise benefits, explored exercise barriers and developed mutual goals with patients. The nurse motivated them and checked the exercise behaviors to ensure adherence to the recommended exercise regime. The nurse case managers interviewed the patients weekly for six weeks and biweekly for another six weeks.

Behavioral: Nurse-led interviewing

Brief group exercise

ACTIVE COMPARATOR

Participants received the in-center exercise training (20 minutes) before hemodialysis sessions weekly for 6 weeks and were instructed to perform exercise at home. The in-center training was conducted by the researcher with a group of four-to six participants focusing on flexibility and strengthening exercise only.

Other: Brief group exercise

Interventions

Nurse-led interviewing BEHAVIORAL

Participants in experimental arm received regular face-to-face interviews during dialysis sessions conducted by the designated case managers every week for 6 weeks and biweekly for another 6 weeks.

Nurse-led interviewing

Brief group exercise OTHER

Participants in this arm only participated in the brief in-center exercise training. They received usual care from the nurse without the interviews and mutual goals developed.

Brief group exercise

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dialysis for \>3 months;
• Age \> 18 years;
• Kt/V (dialysis adequacy) \>1.2;
• Hemoglobin level \> 8g/dl;
• Ambulatory without assistance ;
• Able to communicate in Chinese;
• Able to and willing to provide consent.

You may not qualify if:

• Unstable physical conditions or severe musculoskeletal diseases that might hinder exercise training;
• Severe hearing impairment;
• Diagnosed with mental diseases;
• Meeting or exceeding the exercise recommendation.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

The Second Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (2)

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

  PMID: 35018639 DERIVED

• Tao X, Chow SK, Wong FK. A nurse-led case management program on home exercise training for hemodialysis patients: A randomized controlled trial. Int J Nurs Stud. 2015 Jun;52(6):1029-41. doi: 10.1016/j.ijnurstu.2015.03.013. Epub 2015 Mar 26.

  PMID: 25840898 DERIVED

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Susan KY Chow, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

CN (2)