Clinical trial NCT05427344: Effectiveness of Aquatic Exercise on Fatigue, Neuropathy and Quality of Life Among Cancer Patients
Official title: Effectiveness of Cancer Patients' Aquatic Exercise Program for Cancer-related Fatigue, Cancer-related Neuropathy, Activity and Participation, Quality of Life and Return to Work: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colon Cancer
Breast Cancer
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Hadassah Medical Organization
First posted: 2022-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The majority of cancer patients experience exhaustion, fatigue, and neuropathy that impact their participation in daily activities and reduce their quality of life. In addition, they may affect the ability to function at work and delay a return to employment. Studies have demonstrated that physical activity has a positive effect and consequently, patients being treated for cancer are advised to avoid inactivity. Various studies have described Tai Chi practice as beneficial in reducing exhaustion and fatigue to some extent, and have suggested that it may improve the quality of life of cancer patients. The environment in which physical activity takes place is also important. The properties of water and their effect on the submerged human body may be particularly beneficial for cancer patients. A previous study among breast cancer patients reported that exercise in deep water significantly reduced exhaustion and fatigue compared to patients who received only regular treatment. The practice of Tai Chi in water is termed Ai Chi.

The objectives of the present study are to examine the effects of an Ai Chi program as compared to an intervention group undergoing identical physical exercise on land, and a third group with no additional exercise in cancer patients on:(A)time to return to work, work hours, perception of work-related difficulties, and work absenteeism;(B)activity and participation in the daily life and quality of life; and(C)exhaustion, fatigue, and neuropathy.

This is a randomized clinical trial. 150 cancer patients aged 18-65 years will be recruited. Subjects who meet the recruitment criteria will be randomly divided into one of three groups:(a)Water exercise (Ai Chi);(b)Identical land exercise; and(c)Control-who will not perform additional physical activity or receive any extra treatments. The exercise program will be scheduled for 30 minutes twice a week for 8 weeks. Research tools include:(1)WHODAS 2.0;(2)EORTC QLQ-C30; (3)Piper Fatigue Scale;(4) Employment Barriers Questionnaire;(5) Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20);and(6)Date of return to work and duration of working hours - self-report by the study participants.

Data will be collected before the intervention, after 8 weeks of intervention, and then at 3, 12, and 24 months from the end of the intervention. The investigators will perform a series of mixed variance analyzes to identify relationships and associations between groups and with time within a group (independent variables).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer (stage 3 colon cancer patients and breast cancer patients with lymph node involvement). recruitment of colorectal cancer patients and breast cancer patients for the study will be within 3 months of cessation of chemotherapy treatment.
* a score above 26 on the cognitive MOCA test.

Exclusion Criteria:

* Volunteers with orthopedic disabilities / injuries that in the opinion of the attending physician prevent their participation in physical exercise
* Volunteers engaged in other physical activity on a regular basis

Primary outcomes:
measure: Changes in degree of activity and participation before the start of the intervention (at baseline) and 8 weeks of intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
measure: Changes in degree of activity and participation before the start of the intervention (at baseline) and 3 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention
measure: Changes in degree of activity and participation, before the start of the intervention (at baseline), and 12 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline), and 12, months from the end of the intervention.
measure: Changes in degree of activity and participation before the start of the intervention (at baseline) and 24 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention.
measure: Changes in Quality of life before the start of the intervention (at baseline) and 8 weeks of intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
measure: Changes in Quality of life before the start of the intervention (at baseline) and 3 months from the end of the intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention
measure: Changes in Quality of life before the start of the intervention (at baseline) and 12 months from the end of the intervention
timeFrame: Data will be collected before the start of the intervention (at baseline), and 12 months from the end of the intervention.
measure: Changes in Quality of life before the start of the intervention (at baseline) and 24 months from the end of the intervention
timeFrame: Data will be collected before the start of the intervention (at baseline), and 24 months from the end of the intervention.
measure: Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 8 weeks of intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
measure: Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 3 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention
measure: Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 12 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention
measure: Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 24 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention
measure: Changes in Employment before the start of the intervention (at baseline) and 8 weeks of intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
measure: Changes in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention
measure: Changes in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention
measure: Changes in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention
measure: Changes in Neuropathy before the start of the intervention (at baseline) and 8 weeks of intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
measure: Changes in Neuropathy before the start of the intervention (at baseline) and 3 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention
measure: Changes in Neuropathy before the start of the intervention (at baseline) and 12 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention
measure: Changes in Neuropathy before the start of the intervention (at baseline) and 24 months from the end of the intervention.
timeFrame: Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention
measure: Changes in duration of working hours before the start of the intervention (at baseline) and 8 weeks of intervention
timeFrame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
measure: Changes in duration of working hours before the start of the intervention (at baseline) and 3 months from the end of the intervention.
timeFrame: Chang in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.
measure: Changes in duration of working hours before the start of the intervention (at baseline) and 12 months from the end of the intervention.
timeFrame: Chang in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.
measure: Changes in duration of working hours before the start of the intervention (at baseline) and 24 months from the end of the intervention.
timeFrame: Chang in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassa Hospital
Study officials:
affiliation: Tel Aviv University
name: Navah Z Ratzon, Prof
role: PRINCIPAL_INVESTIGATOR
References: