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临床试验/NCT06641570
NCT06641570已完成不适用

Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

Instituto Politécnico de Leiria1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2024年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Pain

研究概览

简要总结

The goal of this randomized clinical trial] is to study the effect of a combined aquatic and land-based exercise program compared to an aquatic program on pain, functional disability, and quality of life in adults with chronic low back pain. The main question it aims to answer is: "Does a combined aquatic and land-based exercise program improve functional disability and quality of life and reduce pain in adults with chronic low back pain?".

Participants will perform an aquatic exercise program (control group) or a combined aquatic and land-based exercise program (experimental group).

Researchers will compare groups to find any differences in pain, funcional disability and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both gender;
  • Portuguese nationality;
  • Aged over 18 years;
  • Chronic Low Back Pain lasting three months or longer and with an intensity of 3 or higher on the Visual Analogue Scale at rest.

排除标准

  • Individuals who refuse to participate or do not provide informed consent;
  • Pain radiating to the lower limb;
  • Recent pregnancy or childbirth (less than 8 weeks ago);
  • Ongoing physical therapy treatments;
  • Severe rheumatological, neurological, neoplastic, cardiovascular diseases or other conditions that could prevent full participation in the intervention;
  • History of spinal surgery;
  • Inflammatory, infectious, or malignant spinal diseases;
  • Psychiatric disorders that may affect adherence and symptom assessment.

研究组 & 干预措施

Aquatic Exercise Program + Land-exercise Program

Experimental

This intervention will include 8 sessions in 8 weeks, once a week. Each session will last between 25 to 35 minutes and will be divided into two components: core stability exercises and stretching of the trunk and lower limbs.

Core Stability Exercises: These will consist of isometric exercises maintained for 7-8 seconds, 8-12 repetitions, 1 set, with brief rest intervals of 3 seconds between repetitions and 30 seconds to 1 minute between exercises. Exercises will include abdominal hollowing, side bridge (both sides), supine extension bridge, lower limb extension from prone (both sides), and alternate arm and leg raise from quadruped.

Stretching Exercises: Participants will perform muscle stretching exercises, holding the maximum stretch for 30 seconds to 1 minute, and returning to the original position, followed by 5 to 10 seconds of rest. Each exercise will be repeated two to three times. Stretches will target the hamstrings, iliopsoas, piriformis, and tensor fasciae latae.

干预措施: Aquatic Exercise Program (Other)

Aquatic Exercise Program + Land-exercise Program

Experimental

This intervention will include 8 sessions in 8 weeks, once a week. Each session will last between 25 to 35 minutes and will be divided into two components: core stability exercises and stretching of the trunk and lower limbs.

Core Stability Exercises: These will consist of isometric exercises maintained for 7-8 seconds, 8-12 repetitions, 1 set, with brief rest intervals of 3 seconds between repetitions and 30 seconds to 1 minute between exercises. Exercises will include abdominal hollowing, side bridge (both sides), supine extension bridge, lower limb extension from prone (both sides), and alternate arm and leg raise from quadruped.

Stretching Exercises: Participants will perform muscle stretching exercises, holding the maximum stretch for 30 seconds to 1 minute, and returning to the original position, followed by 5 to 10 seconds of rest. Each exercise will be repeated two to three times. Stretches will target the hamstrings, iliopsoas, piriformis, and tensor fasciae latae.

干预措施: Land-based Exercise Program (Other)

Aquatic Exercise Program

Active Comparator

This intervention will include 16 sessions of an aquatic-exercise program, twice a week, over 8 weeks at a water temperature between 32-34°C. Each session will be conducted in groups of 8 to 12 patients and will last about 45 minutes.

The aquatic exercise sessions will include a warm-up phase: walking forwards, sideways, and backwards; a training phase: active range of motion exercises for the spine, upper and lower limbs; aerobic exercises with jumps and static running at various speeds; muscle strengthening, 8-12 repetitions, 1-2 sets, 8-10 exercises including hip flexion, extension, adduction, and abduction, knee flexion and extension, knee cycling, shoulder flexion, extension, and abduction, elbow flexion, extension, and pronation-supination, squatting, and stretching exercises for the neck, trunk, and limbs; and a relaxation/cool-down phase: including lying supine and low-impact exercises such as slow walking, squatting, and standing.

干预措施: Aquatic Exercise Program (Other)

结局指标

主要结局

Pain

时间窗: From enrollment to the end of treatment at 8 weeks

Quantitive variable evaluated with Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.

Functional Disability

时间窗: From enrollment to the end of treatment at 8 weeks

Quantitive variable evaluated with Oswestry Disability Index - version 2.0. (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.

Quality of life

时间窗: From enrollment to the end of treatment at 8 weeks

Quantitive variable evaluated with MOS Short Form Health Survey 36 Item v2. (Minimum: 0; Maximum 100). Higher values correspond to better outcome.

次要结局

  • Lumbar spine range of motion(From enrollment to the end of treatment at 8 weeks)
  • Fear of movement or (re)injury(From enrollment to the end of treatment at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joana Catarina Carvalho Borges

Principal Investigator

Instituto Politécnico de Leiria

研究点 (1)

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