Effectiveness of Aquatic Exercise on Fatigue, Neuropathy and Quality of Life Among Cancer Patients

NCT05427344 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-26

No results posted yet for this study

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).

Conditions

Interventions

OTHER

Water exercise group

Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi.

OTHER

Land exercise group

Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land.

OTHER

Control group

Control group who will not perform additional physical activity or receive any extra treatments.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER
  • Tel Aviv University

    lead OTHER

Principal Investigators

  • Navah Z Ratzon, Prof · Tel Aviv University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-11-23
Completion
2024-11-23

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427344 on ClinicalTrials.gov