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Quality of LifeNCT04506840

Physical Activity and Motivation in Colorectal Cancer Patients

A study testing Physical activity in people with Quality of Life and Physical Exercise, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The intervention will be a physical exercise program for colorectal cancer patients during the adjuvant chemotherapy. The exercise program aims on reducing the side effects of the treatment and improving patients' quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life, Physical Exercise, Motivation
What is being tested?
Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesSpain
Study dates
21 Jan 2020to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being more than 18 years
  • Colorectal cancer stage II and III
  • Be receiving adjuvant chemotherapy treatment after surgery
  • Ecog > 1
  • No medical contraindications

Who cannot join

  • Have a disability
  • Colorectal cancer stage IV
  • Presence of metastasis
  • Ecog < 1

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Universidad Miguel Hernández

    Elche, Elche/Alicante, 03202

  • Hospital Universitario Puerta de Hierro

    Madrid, Majadahonda/Madrid, 28222

Other trials in Spain

About this study

Official title: Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients

The intervention will be a physical exercise program for colorectal cancer patients during the adjuvant chemotherapy. The exercise program aims on reducing the side effects of the treatment and improving patients' quality of life. In addition, the investigators try to improve endurance and resistance training level, in order to achieve greater physical functionality, survival and general well-being. For this, the investigators will carry out an exercise program based mainly on muscular strength and cardiorespiratory condition. It will last 6 months, with a frequency of 3 days per week, including sessions of 60 minutes. Sessions will consist of three parts: warm-up, main part (endurance and resistance training), and cool down. An individualized and supervised progression of training will take place. The intensity levels will always be adjusted to the initial levels of the participants, always considering their preferences and comfort.

Participants' preferences and exercise history will be considered through an initial interview. Motivational strategies based on self-determination theory will be applied, since it is one of the most used theories in the field of physical exercise. This theory proposes that all people need to feel competent, autonomous and socially related. If these three needs are satisfied, participants will develop more positive (autonomous) forms of motivation, which are related to better consequences such as vitality, enjoyment, quality of life and adherence to physical activity. In addition, motivational strategies will be applied for families and healthcare professionals.

Read more

Before starting the program and at the end of it, each eligible patient will be evaluated through:

  • Physical activity: strength test of lower and upper limbs, agility test, stress test for cardiorespiratory fitness, physical activity levels, physical condition and body composition.
  • Psychological factors: autonomy support, basic psychological need satisfaction, motivation, quality of life, perceived barriers, depression, anxiety, hope, quality of life.
  • Clinical parameters: survival rate, side effects, biological factors, treatment delays and planned treatment completion.
Read the detailed description

Objectives and justification of the project In Spain, cancer is the second cause of death after cardiovascular diseases. However, if it is divided by sex, cancer is the leading cause of death for men and the second cause for women. In recent years there has been an increase in new cases of cancer due to population growth and aging, since 2/3 of cancer patients are older than 65 years. In addition to the impact of this disease on people's quality of life, a high economic cost has been estimated for the health system. For example, the total cost of cancer in 2015 in Spain was 7,168 million euros. This situation represents an important public health problem and therefore implies that research on the factors that can prevent or alleviate this disease should be considered as a priority.

In this regard, there is increasing scientific evidence of the physical and psychosocial benefits of exercise both during and after the treatment of this disease. Nevertheless, only 30-40% of cancer survivors perform the necessary physical activity (PA) recommended by the main medical institutions. In fact, a significant number of patients are obese (33%) and have a low cardiorespiratory condition (45%). Despite this, PA continues to decrease after diagnosis and only 5-10% of patients are physically active during treatment and 20-30% after treatment. Therefore, the development of intervention programs aimed at promoting PA should be a fundamental objective in the fight against cancer and its physical and psychosocial consequences. In this line, our general objective will be to develop a motivation PA program for colorectal cancer patients. Specifically, and considering the gaps existing in the current literature, our general objective is subdivided into the following specific objectives:

  • To evaluate the physical, psychosocial and behavioural effects, in the short and medium term, of a physical exercise program in which motivational strategies based on self-determination theory are applied.
  • To explore qualitatively the benefits of the physical exercise program, as well as the troubles encountered in its implementation.
  • To develop an educational guide and an intervention protocol to encourage motivation and adherence to PA of colorectal cancer patients.

Methodology This study will require a sample size of 34 patients. This calculation was made through the G*power software, by means of an analysis of variance (ANOVA), adjusting the values to p <.05, with a statistical power of 80% and an effect size of 0.5. The patients will be recently diagnosed with colorectal cancer in phases II-III by the oncology service of the Hospital Universitario Puerta de Hierro de Majadahonda. Inclusion criteria include to be between 18 and 75 years old, to be undergoing chemotherapy treatment, and to not have any type of associated pathology that prevents them from performing PA. A intervention with an experimental group and a control group will be conducted, where 17 patients will be assigned to a control group, and 17 patients will perform a supervised motivational exercise program.

Measures Cardiorespiratory fitness. Stress tests adapted to the characteristics of the patients will be performed, both in the type of ergometer and in the protocol. We will use electrocardiographic recording and gas exchange analysis. Aerobic and anaerobic exercise thresholds will be established.

Quality of life. The validated Spanish version of the EORTC-QLQ-CR30 will be used for patients with colorectal cancer.

Body composition. Anthropometries will be carried out to estimate body composition parameters.

Biological parameters. The usual analytics carried out in the hospital during the treatment will be used to check the patient's health status and the side effects of the chemotherapy treatment.

Anxiety. The validated version in Spanish of the Hamilton Anxiety Scale will be used.

Depression. The Spanish version of the Hamilton Depression Scale will be used. Autonomy support. The Spanish version of the Perceived Autonomy Support for Exercise Settings will be used.

Perceived barriers to do PA. This scale will be translated and validated to the Spanish context.

Basic psychological needs in exercise. We will use the Basic Psychological Needs in Exercise Scale.

Basic psychological needs in life. The Spanish version of the Basic Psychological Need Satisfaction and Frustration Scale will be used.

Types of motivation. To measure motivation towards PA, the Behavioural Regulation in Exercise Questionnaire will be for PA levels. The Spanish version of the IPAQ questionnaire will be used. On the other hand, PA will be measured in a direct and objective way through portable GT3X accelerometers.

Design, procedure and data analysis The intervention program will be carried out at the Hospital Universitario Puerta de Hierro of Majadahonda. The program will last 6 months, with three weekly one-hour sessions, and will comply with the recommendations established by the American Cancer Society and the American College of Sports Medicine. The safety precautions and contraindications identified by these institutions for colorectal cancer patients will be especially considered. The program will include aerobic sessions at moderate and vigorous intensities, as well as strength work. Patients will be monitored to model exercise loads individually.

The measurements will be made just before starting the PA program (T1) in the case of the experimental group, at an initial time of the equivalent treatment in the case of the control group. The same measures will be carried out 6 months later (T2). For PA levels, instead of measuring them just after the end of the program, we will wait another month so that patients have been able to recover their usual PA levels after the shock that can mean for them to face the end of our program. In the control group, PA levels will also be evaluated one month after T2. To test the effects of the program, all measurements will be performed 6 months after T2 in both groups (T3).

Additionally, qualitative methodology will be used, so that the 17 patients of the experimental group will be interviewed to know the factors related to their adherence to the PA program and the benefits perceived by them with their participation. Qualitative data collection will be reinforced with field notes compiled in research diaries by observers who will be present during the development of the program. Relatives and health professionals will also be interviewed to learn their perspective regarding the benefits of the program and adherence to it in these patients.

In order to promote adherence to the program and to educate in autonomous PA habits when it ends, motivational strategies based on the self-determination theory will be used. Specific strategies will be developed for this group, based on previous works and educational guides for colorectal cancer patients. The instructor in charge of directing the program will be trained in several sessions to use motivational strategies based on this theory. Once the program is finished, an educational guide of motivational strategies for the promotion of PA in patients with colorectal cancer will be developed and published from the perspective of self-determination theory.

Being tested
Physical activity
Keywords
Chemotherapy, Exercise, Motivation, Cancer, Well-being
Medical subject headings
Motor Activity, Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activityOther

    Patients will participate in a program of physical exercise. Resistance training, endurance training, balance and flexibility will be trained with the objective to reduce the side effects of chemotherapy and, in order to improve their quality of life

Study groups in NCT04506840
Study groupRoleWhat they receive
Training groupExperimentalParticipants will participate in a program of physical exercise during the adjuvant chemotherapy treatment
Receives: Other: Physical activity
Not training groupNo interventionParticipants will not do any intervention, they only will be perform the pre and post-tests.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory fitness

    Rockport 1-mile walking test

    Measured: Pre intervention

  2. Cardiorespiratory fitness

    Rockport 1-mile walking test

    Measured: In the middle of the intervention (at 3 months)

  3. Cardiorespiratory fitness

    Rockport 1-mile walking test

    Measured: At 6 months after the start of the intervention

  4. Cardiorespiratory fitness

    Rockport 1-mile walking test

    Measured: One year after the start of the intervention

  5. Strength

    Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

    Measured: Pre intervention

  6. Strength

    Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

    Measured: In the middle of the intervention (at 3 months)

  7. Strength

    Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

    Measured: At 6 months after the start of the intervention

  8. Strength

    Handgrip strength is a measure of the maximum static force that a hand can squeeze using a dynamometer

    Measured: One year after the start of the intervention

Secondary outcomes (52)
  1. Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)

    Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales

    Measured: Pre intervention

  2. Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)

    Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales

    Measured: In the middle of the intervention (at 3 months)

  3. Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)

    Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales

    Measured: At 6 months after the start of the intervention

  4. Quality of life (physical function, emotional role, social function, cognitive function and symptoms such a fatigue, anorexia, dyspnea, etc)

    Questionnaire of EORT-QLQ-29 values are assigned between 1 and 4 (1: not at all, 2: a little, 3: quite a bit, 4: a lot) according to the patient's responses to the item, only items 29 and 30 are evaluated with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of impact of the cancer on the patient on each of the scales

    Measured: One year after the start of the intervention

  5. Motivation in exercise context

    Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)

    Measured: Pre intervention

  6. Motivation in exercise context

    Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)

    Measured: In the middle of the intervention (at 3 months)

  7. Motivation in exercise context

    Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)

    Measured: At 6 months after the start of the intervention

  8. Motivation in exercise context

    Questionnaire BREQ-3 (from 1 to 4 points, being from less autonomous types of motivation to more autonomous types of motivation, based on Self-Determination Theory)

    Measured: One year after the start of the intervention

  9. Body composition

    waist and hip circumference/ waist and hip index

    Measured: Pre intervention

  10. Body composition

    waist and hip circumference/ waist and hip index

    Measured: In the middle of the intervention (at 3 months)

  11. Body composition

    waist and hip circumference/ waist and hip index

    Measured: At 6 months after the start of the intervention

  12. Body composition

    waist and hip circumference/ waist and hip index

    Measured: One year after the start of the intervention

  13. Autonomy support questionnaire

    Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support

    Measured: Pre intervention

  14. Autonomy support questionnaire

    Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support

    Measured: In the middle of intervention (at 3 months)

  15. Autonomy support questionnaire

    Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support

    Measured: At 6 months after the start of the intervention

  16. Autonomy support questionnaire

    Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES)Support Scale for Perceived Autonomy in Physical Exercise Contexts (PASSES). From 1 to 7 points, being more score, more perceived support

    Measured: One year after the start of the intervention

  17. Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)

    In general life context (from 1 to 5 points)

    Measured: Pre intervention

  18. Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)

    In general life context (from 1 to 5 points)

    Measured: In the middle of intervention (at 3 months)

  19. Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)

    In general life context (from 1 to 5 points)

    Measured: At 6 months after the start of the intervention

  20. Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)

    In general life context (from 1 to 5 points)

    Measured: One year after the start of the intervention

  21. The scale of Basic Psychological Needs in Exercise (BPNES) will be used

    In exercise context (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)

    Measured: Pre intervention

  22. The scale of Basic Psychological Needs in Exercise (BPNES) will be used

    (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)

    Measured: In the middle of intervention (at 3 months)

  23. The scale of Basic Psychological Needs in Exercise (BPNES) will be used

    (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)

    Measured: At 6 months after the start of the intervention

  24. The scale of Basic Psychological Needs in Exercise (BPNES) will be used

    (from 1 to 5 points, being more score, more satisfaction of basic psychological needs)

    Measured: One year after the start of the intervention

  25. Perceived barriers to physical activity participation questionnaire

    On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.

    Measured: Pre intervention

  26. Perceived barriers to physical activity participation questionnaire

    On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.

    Measured: In the middle of intervention (at 3 months)

  27. Perceived barriers to physical activity participation questionnaire

    On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.

    Measured: At 6 months after the start of the intervention

  28. Perceived barriers to physical activity participation questionnaire

    On this scale, patients are asked how often different barriers (time, pain, cost, fatigue, etc.) have interfered with their participation in physical exercise during cancer treatment.

    Measured: One year after the start of the intervention

  29. Hope State Questionnaire

    Scale of hope state to face the disease

    Measured: Pre intervention

  30. Hope State Questionnaire

    Scale of hope state to face the disease

    Measured: In the middle of intervention (at 3 months)

  31. Hope State Questionnaire

    Scale of hope state to face the disease

    Measured: At 6 months after the start of the intervention

  32. Hope State Questionnaire

    Scale of hope state to face the disease

    Measured: One year after the start of the intervention

  33. Physical condition questionnaire

    International Fitness Scale (IFI)

    Measured: Pre intervention

  34. Physical condition questionnaire

    International Fitness Scale (IFI)

    Measured: In the middle of intervention (at 3 months)

  35. Physical condition questionnaire

    International Fitness Scale (IFI)

    Measured: At 6 months after the start of the intervention

  36. Physical condition questionnaire

    International Fitness Scale (IFI)

    Measured: One year after the start of the intervention

  37. Side effects of the chemotherapy

    Fatigue questionnaire FACIT

    Measured: Pre intervention

  38. Side effects of the chemotherapy

    Fatigue questionnaire FACIT

    Measured: In the middle of intervention (at 3 months)

  39. Side effects of the chemotherapy

    Fatigue questionnaire FACIT

    Measured: At 6 months after the start of the intervention

  40. Side effects of the chemotherapy

    Fatigue questionnaire FACIT

    Measured: One year after the start of the intervention

  41. Physical activity levels (subjective)

    International physical activity questionnaire (IPAQ)

    Measured: Pre intervention

  42. Physical activity levels (subjective)

    International physical activity questionnaire (IPAQ)

    Measured: In the middle of intervention (at 3 months)

  43. Physical activity levels (subjective)

    International physical activity questionnaire (IPAQ)

    Measured: At 6 months after the start of the intervention

  44. Physical activity levels (subjective)

    International physical activity questionnaire (IPAQ)

    Measured: One year after the start of the intervention

  45. Physical activity levels (objective)

    Accelerometer

    Measured: Pre intervention

  46. Physical activity levels (objective)

    Accelerometer

    Measured: In the middle of intervention (at 3 months)

  47. Physical activity levels (objective)

    Accelerometer

    Measured: At 6 months after the start of the intervention

  48. Physical activity levels (objective)

    Accelerometer

    Measured: One year after the start of the intervention

  49. Depression and anxiety

    The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)

    Measured: Pre intervention

  50. Depression and anxiety

    The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)

    Measured: In the middle of intervention (at 3 months)

  51. Depression and anxiety

    The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)

    Measured: At 6 months after the start of the intervention

  52. Depression and anxiety

    The Hospital Anxiety and Depression Scale questionnaire (1-4 scale: never, not very often, sometimes, slmost always, the higher the score worse the result)

    Measured: One year after the start of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start21 Jan 2020
  3. Primary completion30 Jun 2023
  4. Study completion30 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04506840
Sponsor's protocol ID
DPS.DGC.01.19
Status last verified
May 2024
First submitted
21 Jul 2020
Last updated
13 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390
  • Alvero Cruz, J. R., Armesilla, M. D. C., Herrero-de-Lucas, A., Riaza, L. M., Pascual, C. M., Manzañido, J. P., … Belando, J. E. S. (2010). Body composition assessment in sports medicine. Statement of Spanish group of kinanthropometry of Spanish federation of sports medicine. Version 2010. Archivos de Medicina del Deporte, 27, 330-344.

  • Arraras JI, Suarez J, Arias de la Vega F, Vera R, Asin G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.

    PubMed 21239355
  • Courneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999b). Understanding exercise motivation in colorectal cancer patients: A prospective study using the theory of planned behavior. Rehabilitation Psychology, 44, 68-84.

  • Courneya, K. S., Friedenreich, C. M., Arthur, K., y Bobick, T. M. (1999a). Physical exercise and quality of life in postsurgical colorectal cancer patients. Psychology, Health, & Medicine, 4, 181-187.

  • Courneya KS, Friedenreich CM, Quinney HA, Fields AL, Jones LW, Fairey AS. Predictors of adherence and contamination in a randomized trial of exercise in colorectal cancer survivors. Psychooncology. 2004 Dec;13(12):857-66. doi: 10.1002/pon.802.

    PubMed 15386794
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694
  • Fuller JT, Hartland MC, Maloney LT, Davison K. Therapeutic effects of aerobic and resistance exercises for cancer survivors: a systematic review of meta-analyses of clinical trials. Br J Sports Med. 2018 Oct;52(20):1311. doi: 10.1136/bjsports-2017-098285. Epub 2018 Mar 16.

    PubMed 29549149
  • Garcia DO, Thomson CA. Physical activity and cancer survivorship. Nutr Clin Pract. 2014 Dec;29(6):768-79. doi: 10.1177/0884533614551969. Epub 2014 Oct 21.

    PubMed 25335787
  • HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

    PubMed 13638508
  • HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

    PubMed 14399272
  • Lobo A, Chamorro L, Luque A, Dal-Re R, Badia X, Baro E; Grupo de Validacion en Espanol de Escalas Psicometricas (GVEEP). [Validation of the Spanish versions of the Montgomery-Asberg depression and Hamilton anxiety rating scales]. Med Clin (Barc). 2002 Apr 13;118(13):493-9. doi: 10.1016/s0025-7753(02)72429-9. Spanish.

    PubMed 11975886
  • Ng JY, Ntoumanis N, Thogersen-Ntoumani C, Deci EL, Ryan RM, Duda JL, Williams GC. Self-Determination Theory Applied to Health Contexts: A Meta-Analysis. Perspect Psychol Sci. 2012 Jul;7(4):325-40. doi: 10.1177/1745691612447309.

    PubMed 26168470
  • Peddle CJ, Plotnikoff RC, Wild TC, Au HJ, Courneya KS. Medical, demographic, and psychosocial correlates of exercise in colorectal cancer survivors: an application of self-determination theory. Support Care Cancer. 2008 Jan;16(1):9-17. doi: 10.1007/s00520-007-0272-5. Epub 2007 Jun 15.

    PubMed 17569994
  • Rantanen T, Guralnik JM, Foley D, Masaki K, Leveille S, Curb JD, White L. Midlife hand grip strength as a predictor of old age disability. JAMA. 1999 Feb 10;281(6):558-60. doi: 10.1001/jama.281.6.558.

    PubMed 10022113

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Quality of Life and Physical Exercise, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory fitness (time frame: Pre intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04506840, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.

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