Exercise Intervention for Chemotherapy-Induced Peripheral Neuropathy
3 juni 2026 bijgewerkt door: Seethalakshmi Avudaiappan, Sri Ramachandra Institute of Higher Education and Research
Prevalence and Effectiveness of Exercise on Chemotherapy-induced Peripheral Neuropathy Among Oncology Patients
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that can negatively impact patients' functional status and quality of life.
This study was conducted in two phases among oncology patients receiving chemotherapy at a tertiary care teaching hospital in Chennai, India.
Phase I used a descriptive survey design to determine the prevalence of CIPN.
Phase II employed a randomized controlled experimental design to evaluate the effectiveness of a structured exercise program in reducing CIPN symptoms among patients with mild to moderate CIPN.
Eligible participants were randomly assigned to intervention and control groups.
The intervention group received education and supervised exercises involving lower and upper extremity movements, while the control group received routine care.
Outcomes were assessed using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale before and after a 21-day intervention period.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
This quantitative study was conducted in two phases. Phase I assessed the prevalence of chemotherapy-induced peripheral neuropathy among oncology patients receiving chemotherapy. A total of 282 participants were enrolled.
Based on the prevalence findings, Phase II was conducted to determine the effectiveness of a structured exercise program. One hundred and twenty patients with mild or moderate CIPN were randomly allocated into intervention (n=60) and control (n=60) groups using a lottery method. The intervention consisted of education regarding CIPN and a structured exercise program including toe flexion and extension, ankle circles, toe spreading, heel raises, finger extension stretches, pinch grips, and finger circles. Exercises were performed 10-15 repetitions per extremity, 2-3 times daily, for 21 days.
Participants in the control group received routine oncology care. CIPN severity was measured before and after the intervention using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale. Statistical analyses included descriptive statistics, paired t-tests, independent t-tests, and chi-square tests.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
282
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Tamil Nadu
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Chennai, Tamil Nadu, Indië, 600116
- Sri Ramachandra Institute of Higher Education and Research
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age greater than 18 years
- Receiving chemotherapy
- Diagnosed with mild or moderate chemotherapy-induced peripheral neuropathy
- Willing to participate and provide informed consent
Exclusion Criteria:
- Pre-existing peripheral neuropathy unrelated to chemotherapy (e.g., diabetic neuropathy).
- Uncontrolled diabetes mellitus.
- Significant cardiovascular disease.
- Severe musculoskeletal disorders.
- Contraindications to exercise, including recent surgery, bone metastases, or severe anemia.
- Severe mobility limitations.
- Severe mental health conditions affecting participation.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Experimental Arm: Structured Exercise Program
Participants received structured education regarding chemotherapy-induced peripheral neuropathy and performed a supervised exercise program involving lower and upper extremity exercises for 21 days in addition to routine care.
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Patients in the intervention group receive structured education about CIPN, which included its definition, risk factors, signs and symptoms, and management through exercises.
The exercises were demonstrated by the researcher and involved leg toe flexion and extension, ankle circles, toe spreading, heel raises, as well as hand exercises such as finger extension stretches, pinch grips, and finger circles.
Participants were asked to return demonstrate the exercises, continue practicing them under supervision for one to two days during hospitalization for chemotherapy and after discharge for a period of 21 days when they came for their subsequent cycle of chemotherapy.
This was then reinforced using a pamphlet which was provided to the patients, and patients were encouraged to maintain a daily practice
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Geen tussenkomst: Control Arm: Routine Care
Participants received standard oncology care including consultation and medication management according to institutional protocols.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Severity of Chemotherapy-Induced Peripheral Neuropathy
Tijdsspanne: Baseline and Day 21
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Change in CIPN severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
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Baseline and Day 21
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Prevalence of Chemotherapy-Induced Peripheral Neuropathy among oncology patients receiving chemotherapy.
Tijdsspanne: At baseline assessment.
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Prescence of CIPN and its severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.
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At baseline assessment.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2024
Primaire voltooiing (Werkelijk)
1 december 2024
Studie voltooiing (Werkelijk)
1 december 2024
Studieregistratiedata
Eerst ingediend
3 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
3 juni 2026
Eerst geplaatst (Werkelijk)
9 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
3 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 05/185
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be publicly shared.
De-identified data may be available from the corresponding investigator upon reasonable request.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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