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

Tel Aviv University

Status: Withdrawn

Conditions: Breast Cancer; Colon Cancer

Treatments: Other: Control group; Other: Land exercise group; Other: Water exercise group

Study type: Interventional

Funder types: Other

Identifiers

NCT05427344

Michal Nissim 2

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Water exercise group

Experimental group

Description:

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

Treatment:

Other: Water exercise group

Land exercise group

Experimental group

Description:

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

Treatment:

Other: Land exercise group

Control group

Experimental group

Description:

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

Treatment:

Other: Control group