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Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01432067
Acronym
CAPADOGE
Enrollment
302
Registered
2011-09-12
Start date
2011-10-04
Completion date
2016-06-10
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Elderly Population

Keywords

cancer, geriatry, curative care, physical activity

Brief summary

The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

Detailed description

Long-term evolution of successful-treated older patients is not well-known except for survival. They seem more affected by physical than psychological problems. The combined effects of aging, cancer, and treatments on muscle function could have hindered their usual physical activity. Cancer is associated with frailty. Fried and coll have defined a frailty phenotype as a combination of 3 or more of 5 conditions: exhaustion, loss of weight, decreased muscle strength, slow gait speed and low physical activity. Frail subjects have a higher risk of physical or cognitive disability and death. An intervention able to prevent frailty is of great interest for the older cancer patient and their quality of life. An intervention consisting of phone-program in physical activity has been associated with a decrease in self-reported disability in five-year obese survivors from cancer. Patients will be randomized in two arms (1:1 ratio). Arm 1: Physical activity advices according to a program adapted to physical status of the patient assessed using SPPB (short physical performance battery) and the IPAQ questionnaire. A monthly phone support during one year will be performed by an adapted physical activity instructor and delivery of PNNS guide for subjects older than 55 y old. Arm 2: Delivery of PNNS guide for subjects older than 55 year old: recommendation of 1/2 hour physical activity of any kind. Each patient will be followed during 2 years: First visit (V1) will take place before treatment. The subsequent visits will take place at 3 months (V2), 6 months (V3), 1 year (V4), 18 months (V5) and 2 years (V6), in which patients will complete questionnaires (IPAQ, QLQ-C30, one day dietary intakes), have clinical examinations (weight, performance status/ ECOG) and will be tested for physical facilities (SPPB, micro-fet2). These evaluations will be completed by the MMS / Fluency tests and the covered distance during 6 minutes at V1, V3, and V4.

Interventions

OTHERAdapted physical activity

Physical activity advices according to a program adapted to physical status of the patient.

OTHERClassic physical activities

Daily physical activities based on a standard guide

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 70 years old or older * Curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/ or radiotherapy * Patient with histologically proven lymphoma or carcinoma : * Colon, rectum or anal canal Cancer * Breast Cancer * Esophageal cancer * Otolaryngology Cancer * Kidney cancer * hepatocellular carcinoma * Stomach Cancer * Pancreatic cancer * Bile duct cancer * Ovarian Cancer * All lymphoma diffuse large B-cell and all peripheral T-cells lymphomas * All low-grade lymphoma: lymphocytes, lymphocytes and plasma cells, follicular, mantle, marginal zone (MALT and others) * Prostate cancer * Bladder Cancer * Lung cancer * adenocarcinoma of unknown primary origin compatible with previous quoted origin * Performance status (ECOG) \<4 * Patient who had given oral consent to participate in the study

Exclusion criteria

* Palliative cares for cancer

Design outcomes

Primary

MeasureTime frameDescription
SPPB Score1 yearThe main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.
Cognitive skills2 yearsMMS test, verbal fluency

Secondary

MeasureTime frameDescription
Quality of life2 yearsIPAQ, QLQ-C30, ADL, performance status (ECOG)
nutritional status2 years
Walking distance over 6 minutesinclusion, 6 months and 1 year
isometric muscle strength measures of upper and lower limbs2 yearsmicrofet2 test
weight2 years
SPPB score2 years

Countries

France

Contacts

PRINCIPAL_INVESTIGATORIsabelle BOURDEL MARCHASSON, Pr

University Hospital, Bordeaux, France

STUDY_CHAIRAdélaïde DOUSSAU, Dr

University Hospital, Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026