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Smartphone-based exercise intervention for chronic pain: a randomised clinical trial

Efficacy of a smartphone-based exercise therapy intervention on the level of pain, anxiety and depression, sleep and quality of life in patients with chronic pain: a randomised clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000783820
Acronym
PainReApp (Pain Rehabilitation/Relief Application)
Enrollment
99
Registered
2021-06-22
Start date
2021-09-15
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

None listed

Brief summary

Chronic pain (CP) should be understood as a disease in itself, derived from changes in the Central Nervous System, and not as a symptom of another pathology. A multimodal intervention is needed that includes aspects such as physical exercise, diet, social and psychological support. There is evidence that physical exercise has benefits in reducing pain, physical limitations, disability and mental health. The implementation of m-Health technologies constitutes an alternative with proven effects in other patient groups, which improves the therapeutic adherence and autonomy of the patient. Because of this, the development and evaluation of the effectiveness of a m-Health system based on the physical exercise for application in patients with CP respond to a need. Our hypothesis is that a m-health system based on physical exercise recommendations for patients with CP (low back pain, fibromyalgia and diabetic neuropathic pain) will improve pain intensity, presence of anxiety and/or depression, sleep quality and quality of life of this population. Therefore, this project aims to evaluate the effectiveness of a m-health system based on physical exercise recommendations for patients with CP based on its results on pain intensity, presence of anxiety and/or depression, sleep quality and quality of life. The achievement of the present project would serve to analyze the benefits of an exercise program in patients with CP and to identify those patients in whom the benefits would be greater and whose implementation would have greater priority. These results would be part of the future project to develop a multifactorial rehabilitation program based on the biopsychosocial model for patients with non-oncological CP.

Interventions

PainReApp Group Individuals of three different chronic pain conditions will be randomly selected: chronic low back pain, fibromyalgia and diabetic neuropathic pain. The intervention group will complete a program of exercise guided by a m-health system for 24 weeks. Previously, their doctors determined whether patients would be able to exercise regularly. A program of 60 min, 3 times per week, aimed to improve the general conditioning of the patients will be performed, following the recommen

PainReApp Group Individuals of three different chronic pain conditions will be randomly selected: chronic low back pain, fibromyalgia and diabetic neuropathic pain. The intervention group will complete a program of exercise guided by a m-health system for 24 weeks. Previously, their doctors determined whether patients would be able to exercise regularly. A program of 60 min, 3 times per week, aimed to improve the general conditioning of the patients will be performed, following the recommendations of the American College of Sports Medicine for patients with chronic pain. The daily session will be divided into the warm-up, aerobic training, strengthening and calm down. - Warm-up: It will consist of 5 min. walking in a way that allows the patient to have a conversation. - Aerobic training: It will consist of 10 to 20 min. walking so the patient can have a conversation, but having to stop and breathe once in a while. - Strengthening: It will be focused on 7 exercises. a) squats, b) stiff-legged deadlifts, c) lateral pull-down, d) reversed flies, e) flies, f) unilateral rows, and g) lateral raise. - Calm down: It will consist of stretching exercises. a) shoulders, b) triceps, c) chest, d) quadriceps, e) hamstrings, and f) back. Patients will have a first face-to-face session in which the use of the smartphone app and the conditioning program will be explained. This session will be performed in the Hospital Universitario Puerta del Mar (Cádiz, Spain). Strengthening exercises will be performed using an elastic band. During the first session, a physiotherapist will explain how to manage the elongation of the elastic band to increase or decrease the resistance intensity. The general recommendation will be 70-80% 1 repetition maximum that allows the patient to perform 8-10 repetitions. These home exercise sessions will be approximately 60 min. depending on the level of the patient. The PainReApp m-health system will provide videos and descriptions of exercises to be performed. The adherence to the intervention will be monitored through the PainReApp application.

Sponsors

Jose A. Moral-Munoz
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Patients diagnosed with chronic low back pain, fibromyalgia or diabetic neuropathic pain. - Over 18 years. - Absence of cognitive and physical deficits that impede the physical exercise. - Dispose of a smartphone with Internet access. - Ability to understand and write Spanish.

Exclusion criteria

- Concomitant diseases that impede the physical exercise. - Contraindications for physical exercise detected by the doctor. - Participation in moderate-intensity activities (more than 30 minutes 3 times a week) at the time of the study beginning.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026