The Effect of Physiotherapy Program in Patients Undergoing Chemotherapy in Patients With Colon Cancer

NCT06476522 | Completed

• 1 other identifier: AU-BENGUBOZ-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Studies examining the effect of exercise on the side effects of chemotherapy in colon and rectal cancer have found strong evidence for short-term improvements. The aim of this study was to investigate the effect of 12weeks home based physiotherapy program on toxicity, muscle strength, balance, and endurance in patients undergoing chemotherapy in patients with CC. Method: Patients diagnosed with colon cancer (CC) were invited to participate in the study before the start of adjuvant chemotherapy. All patients participating in the study were given general information about the chemotherapy period, possible chemotherapy-related side effects, and coping strategies. The patients were categorized into two groups as control an intervention. Intervention Group were taught and shown the exercises, walking activity, balance and sensory training exercises practically by the physiotherapist. Exercises were performed as home exercises during the 12 weeks. Demographic information and clinical information were recorded. The side effects of toxicity like fatigue, nausea, vomiting, and oral wounds were evaluated with The National Cancer Institute-Common Terminology Criteria for Adverse Events. Iliopsoas, Quadriceps, Gastrosoleus, and Tibialis Anterior muscles strength were evaluated by Manual Muscle Testing. The standing balance was assessed with The one-leg-stance (OLS) timed test. The lower extremity muscle strength and endurance was tested with The 30-sec Chair Stand Test. Sensory evaluations were made with the Semmes Weinstein Monofilament Test and the two-point discrimination test.

Conditions

Colon Cancer; Chemotherapy Effect

Keywords

Exercise; Toxicity; Muscle Strength; Balance; Endurance

Outcome Measures

Primary Outcomes (1)

• Muscle strength

  Iliopsoas, Quadriceps, Gastrosoleus, and Tibialis Anterior muscles strength were evaluated by Manual Muscle Testing. For muscle tests; Dr. Robert W. Lovett explained the muscle strength test method, starting with a value of 3. The 3+, 4, 4+ and 5 values of the muscle that can perform the 3 value were checked. If it cannot reach the value of 3, the values of 2, 1, and 0 were checked.

  change from baseline at 12 weeks

Secondary Outcomes (5)

• Chemotherapy Toxicity

  change from baseline at 12 weeks

• Balance

  change from baseline at 12 weeks

• Endurance

  change from baseline at 12 weeks

• Sensory 1

  change from baseline at 12 weeks

• Sensory 2

  change from baseline at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

The exercises were taught to the patients in the intervention group practically by the physiotherapist so that they could do their exercises at home.

Other: Physiotherapy Program; Other: To Inform

Control

ACTIVE COMPARATOR

The control group patients continued with their routine chemotherapy treatment determined by their doctor. No intervention was made other than routine treatments.

Other: To Inform

Interventions

Physiotherapy Program OTHER

In the first evaluation, 5 different exercises were shown and the patients were asked to do home exercises in accordance with the given program. The physiotherapist suggested starting with a 10-minute walk 5 times a week and then gradually increasing the walking time. The patients were given a program for balance and sensory training. They were asked to apply the physiotherapy program at least 3 days a week for 12 weeks. Weekly follow-up of the patients was carried out by the physiotherapist over the phone or face to face when they underwent routine treatment.

Intervention

To Inform OTHER

The patients were informed that they would be evaluated by the physiotherapist when they came to the routine doctor's control in the first week and at the end of the 12 weeks. At the end of 12 weeks, these patients were also given home-based exercise program advice.

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• \> 18 years of age,
• diagnosed with stage 2-3 colon cancer
• scheduled to receive adjuvant chemotherapy
• able to read, write and understand Turkish.

You may not qualify if:

• cardiopulmonary disease, nerve, muscle, or joint disease, affecting movement
• malignant tumors
• postoperative heart, cerebral vessel, or other mental
• illness or serious cognitive impairment and defects in language serious complications
• \< 18 kg Body Mess Index

Sponsors & Collaborators

• Atılım University: lead

Study Sites (1)

Gazi University

Ankara, Yenimahalle, 06570, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colonic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Behavior

Study Officials

• İlke KESER, Assoc. Prof.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Group and Control Group

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: June 26, 2024
• Study Start: October 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

TU (1)