Severe Fatigue in Stem Cell Transplantation

NCT03448471 | Completed

• 1 other identifier: GaziUniversity4
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is a common symptom during allogeneic-hematopoietic stem cell transplantation (allo-HSCT). However, effects of severe fatigue on pulmonary functions, blood cells, dyspnea, muscle strength, exercise capacity, depression and quality of life (QOL) in allo-HSCT recipients are still unknown.

Conditions

Stem Cell Transplantation; Fatigue

Keywords

stem cell transplantation; Fatigue; muscle strength; exercise capacity; Depression; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Peripheral muscle strength

  Evaluated with a hand-held dynamometer

  First day

Secondary Outcomes (7)

• 6-minute walking test

  First day

• Respiratory muscle strength

  First day

• Pulmonary function test

  First day

• Fatigue Severity Scale

  First day

• Modified Medical Research Council Dyspnea scale (MMRC)

  First day

Study Arms (2)

Group 1: severe-fatigued recipients

These recipients had Fatigue Severity Scale score ≥36. All recipients evaluated with similar methods. Meaurements were Pulmonary function tests, Respiratory muscle strength, Peripheral muscle strength, Functional exercise capacity, Dyspnea, Fatigue, Depression and Quality of life.

Group 2: non-severe-fatigued recipients

These recipients had Fatigue Severity Scale score \<36. All recipients evaluated with similar methods. Meaurements were Pulmonary function tests, Respiratory muscle strength, Peripheral muscle strength, Functional exercise capacity, Dyspnea, Fatigue, Depression and Quality of life.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Forty-nine allogeneic-HSCT recipients who were at minimum 100 days status post-transplantation, between ages of 18 and 65, under standard medical treatment, transplanted at Bone Marrow Transplantation Unit of University Faculty of Medicine were included. Twenty four severe-fatigued (Fatigue Severity Scale score ≥36) and 25 non-severe-fatigued recipients were compared.Study was approved by local Ethics Committee and informed consent was obtained from all individual participants included in study.

You may qualify if:

• being an hematopoietic stem cell transplantation recipient during the intermediate/late post-transplant phase (\>100 days),
• years of age
• under standard medications.

You may not qualify if:

• having a cognitive disorder,
• orthopedic or neurological disease with a potential to affect functional capacity,
• comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia,
• problems which may prevent training such as visual problems and mucositis
• having metastasis to any region (bone etc.)
• having acute hemorrhage in the intracranial and / or lung and other areas
• having any contraindication to exercise training

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (6)

• Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.

  PMID: 21765268 RESULT

• Soutar RL, King DJ. Bone marrow transplantation. BMJ. 1995 Jan 7;310(6971):31-6. doi: 10.1136/bmj.310.6971.31. No abstract available.

  PMID: 7827553 RESULT

• Papadopoulos EB, Jakubowski AA. Novel approaches in allogeneic stem cell transplantation. Curr Oncol Rep. 2006 Sep;8(5):325-36. doi: 10.1007/s11912-006-0054-0.

  PMID: 16901394 RESULT

• Wulff-Burchfield EM, Jagasia M, Savani BN. Long-term follow-up of informal caregivers after allo-SCT: a systematic review. Bone Marrow Transplant. 2013 Apr;48(4):469-73. doi: 10.1038/bmt.2012.123. Epub 2012 Jun 25.

  PMID: 22732697 RESULT

• Polomeni A, Lapusan S, Bompoint C, Rubio MT, Mohty M. The impact of allogeneic-hematopoietic stem cell transplantation on patients' and close relatives' quality of life and relationships. Eur J Oncol Nurs. 2016 Apr;21:248-56. doi: 10.1016/j.ejon.2015.10.011. Epub 2015 Nov 18.

  PMID: 26602410 RESULT

• Frodin U, Lotfi K, Fomichov V, Juliusson G, Borjeson S. Frequent and long-term follow-up of health-related quality of life following allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2015 Nov;24(6):898-910. doi: 10.1111/ecc.12350. Epub 2015 Jul 7.

  PMID: 26156141 RESULT

MeSH Terms

Conditions

Fatigue; Depression

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Gülşah Barğı, PhD.

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, PhD.

  Gazi University

  STUDY DIRECTOR

• Gülsan Türköz Sucak, PhD.

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: March 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)